Safety blood collection assembly with indicator

ABSTRACT

A needle assembly is disclosed. The needle assembly includes a housing having a flash chamber, and having a distal end and a proximal end engageable with a specimen collection container. The assembly includes a cannula having a patient end, a non-patient end, and a sidewall extending therebetween defining a cannula interior. The patient end of the cannula projects at least partially from the distal end of the housing, and the cannula interior is in fluid communication with the flash chamber. The assembly further includes a shield restrainably engaged with a portion of the housing and axially transitionable over the patient cannula from a retracted position in which the patient end is exposed, to an extended position in which the patient end is shielded by at least a portion of the shield, wherein at least a portion of the flash chamber is visible in the retracted position.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of, and claims priority to,U.S. patent application Ser. No. 13/050,572, filed Mar. 17, 2011,entitled “Safety Blood Collection Assembly with Indicator”, which is acontinuation of, and claims priority to, U.S. patent application Ser.No. 12/044,469 filed Mar. 7, 2008, entitled “Safety Blood CollectionAssembly with Indicator” which claims priority to U.S. ProvisionalApplication Ser. No. 60/941,870 filed Jun. 4, 2007, and U.S. ProvisionalApplication Ser. No. 60/893,519 filed Mar. 7, 2007, the entiredisclosure of each application is herein incorporated by reference.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates generally to shieldable safety needleassemblies and, more particularly, to needle assemblies having ahousing, a needle cannula, and a shield restrainably engaged with aportion of the housing.

Description of Related Art

Typical needle assemblies include a needle cannula having a proximalend, a pointed distal end with a puncture tip, and a lumen extendingtherebetween. A thermoplastic hub is often mounted securely to theneedle cannula at a location spaced apart from the distal end. The hubis typically provided with external threads or other surfaceconfigurations for mounting the needle cannula to another structure.Some needle assemblies are used for drawing a specimen, such as a sampleof blood or other bodily fluid, from a patient.

A needle assembly that is used to draw a sample of blood or other bodilyfluid is typically used in association with a housing. Needle cannulaeused in association with these assemblies typically have pointedproximal and distal ends, and the needle hub is mounted to a locationbetween the opposed ends of the needle cannula. The housing typicallyincludes a substantially tubular sidewall with a widely opened proximalend, and a partly closed distal end. The hub of the prior art needleassembly can be engaged with the partly closed distal end of the needleholder. Thus, the pointed proximal end of the needle cannula projectsinto the needle holder for engagement with an evacuated tube, while thepointed distal end of the needle cannula projects distally beyond theneedle holder for puncturing the patient's skin.

The needle assembly is often used with a specimen collection tube fordrawing a sample of blood or other bodily fluid from a patient. Thespecimen collection tube typically includes a closed end, an open end,and a sidewall extending therebetween. The tube is typically evacuated,and the open end is sealed by a septum that retains the vacuum withinthe tube. The evacuated tube is dimensioned to be slid into the openproximal end of the needle holder. Sufficient sliding of the evacuatedtube into the needle holder causes the proximal point of the needlecannula to pierce the septum of the evacuated tube. Thus, the needlecannula can be placed in communication with the interior of theevacuated tube.

The combined needle assembly and evacuated tube is employed by initiallyurging the pointed distal end of the needle cannula into a blood vesselof a patient. Once the targeted blood vessel has been accessed, theevacuated tube is urged into the needle holder such that the proximalpoint of the needle cannula pierces the septum of the tube. Low pressureconditions within the evacuated tube, as well as the patient's ownvasculature pressure, generate a flow of blood from the patient throughthe needle cannula and into the evacuated tube. The evacuated tube maybe removed from the needle holder after a sufficient quantity of bloodhas been collected. One or more additional evacuated tubes may similarlybe urged into the open end of the needle holder for drawing one or moreadditional samples of blood to be analyzed. The needle cannula is thenwithdrawn from the patient after a sufficient volume of blood has beencollected for the required analytical procedure. In order to reduce therisk of an accidental needle stick, or contact that could transmitpathogens from the patient to the medical practitioner, the needlecannula must be properly shielded after contact with the patient.

Many types of devices are available for shielding a used needle cannula.Example shielding devices include those disclosed in U.S. Pat. Nos.5,348,544; 5,242,417; 6,592,556; 6,635,032; and 7,001,363, the entiredisclosures of which are herein incorporated by reference. Most shieldedneedle assemblies are effective at performing their primary function,i.e., shielding a used needle cannula. However, many medicalpractitioners consider the available shieldable needle assembliescumbersome. Additionally, in some cases, practitioners may be rushingand forget to operate the safety shield. Other situations arise wherethe patient moves suddenly or unexpectedly. Thus, the needle cannula mayinadvertently be pulled out of the vein and exposed with no time for thephlebotomist to initiate safety shielding.

Another problem with many prior art blood collection devices relates tothe time required to assure venous entry. In particular, blood willbegin to flow through the cannula upon entry of the intravenous ordistal end of the cannula into the vein. However, air present in thecannula, and in the multiple sample sleeve that covers the non-patientend of the cannula, will resist the flow of blood into and through thecannula. In response, the medical practitioner will typically urge anevacuated tube into the needle holder once the practitioner isreasonably sure that the vein has been entered. The rubber stopper atthe end of the evacuated tube will deform the multiple sample sleeveover the non-patient end of the cannula and will permit the non-patientend of the cannula to enter the evacuated tube. The pressuredifferential between the evacuated tube and the cannula will cause theblood to flow into the evacuated tube. In conventional needleassemblies, this often provides the first visual assurance that the veinhas been accessed properly.

However, there are many instances in which a medical practitioner willproperly access a vein with the distal end of the needle cannula, butwill mistakenly believe that the vein has not been entered. Hence, thepractitioner will make a second attempt to access the vein. This adds tothe discomfort for the patient, extends the time required to carry out ablood collection procedure, and increases the risk for accidentalcontact between the medical practitioner and a cannula that has beenexposed to the patient's blood. Additionally, in some instances apassive shielding mechanism will be activated when the cannula iswithdrawn from the patient, thereby making the needle cannula unusableand requiring the medical practitioner to obtain a new needle assembly.

SUMMARY OF THE INVENTION

A need continues to exist for safety needle assemblies incorporatingboth a visual flash indicator and a safety shield that can betransitioned from a retracted position in which the tip of a needlecannula is exposed, to an extended position in which the tip of theneedle cannula is shielded, which minimizes the risk of exposure tomedical personnel, is convenient to use, and is cost-effective.

In one embodiment of the present application, a needle assembly includesa housing having a flash chamber, the housing having a distal end and aproximal end engageable with a specimen collection container. The needleassembly includes a cannula having a patient end, a non-patient end, anda sidewall extending therebetween defining a cannula interior. Thepatient end of the cannula projects at least partially from the distalend of the housing, and the cannula interior in fluid communication withthe flash chamber. The needle assembly also includes a shieldrestrainably engaged with a portion of the housing. The shield isaxially transitionable over the patient cannula from a retractedposition in which the patient end is exposed, to an extended position inwhich the patient end is shielded by at least a portion of the shield.At least a portion of the flash chamber is visible in the retractedposition.

The flash chamber may be visible through at least a portion of theshield in the retracted position. In one configuration, the portion ofthe shield through which the flash chamber is visible is transparent ortranslucent. In another configuration, the shield includes anobservation window, and the flash chamber is visible through theobservation window in the retracted position. The patient end of thecannula may include a bevel, and the position of the observation windowwithin the shield may correspond to the orientation of the bevel.

In one configuration, the proximal end of the housing defines a specimencollection container receiving port. A removable seal may be disposedover a portion of the specimen collection container receiving port.Alternatively, a rupturable seal may be disposed over a portion of thespecimen collection container receiving port.

The shield may at least partially surround the patient end of thecannula in the extended position. Optionally, the shield issubstantially circumferentially disposed about at least a portion of thecannula, and transition of the shield from the retracted position to theextended position telescopes the shield over the cannula. In certainembodiments, the sidewall of the cannula defines an opening extendingbetween the cannula interior and the flash chamber. In otherembodiments, the cannula includes at least two distinct needle portions,such as a patient needle in fluid communication with the flash chamber,and a non-patient needle in fluid communication with the flash chamber.The patient needle may project at least partially from the distal end ofthe housing, and the non-patient needle may extend in a substantiallyproximal direction from the patient cannula. In one embodiment, thespecimen collection container engageable at the proximal end of thehousing is a blood collection container.

The flash chamber may be integrally formed within a portion of thehousing. In certain configurations, the housing includes a hubsupporting at least a portion of the cannula, and the flash chamber isintegrally formed with the hub. A porous vent may be disposed within theflash chamber such that the porous vent separates the flash chamber intoa first chamber and a second chamber. The first chamber and the secondchamber may be configured such that upon insertion of the patient end ofthe cannula into a patient, blood flows through the cannula and into thefirst chamber without sealing the porous vent. Upon application of anevacuated specimen collection container to the non-patient end of thecannula, blood may be drawn from the first chamber and air may be drawnfrom the second chamber, thereby establishing a negative pressure withinthe second chamber with respect to an external environment of the flashchamber. Alternatively, the flash chamber may include a vent mechanismin communication with an environment surrounding the needle assembly.The porous vent may include a plurality of pores for passage of bloodtherethrough from the first chamber to the second chamber. The ventmechanism may be a porous plug formed of a hydrophobic material, aone-way valve, or a porous plug formed of a hydrophilic material thatswells on contact with blood.

The shielding portion of the shield may be restrainably engaged withinan interior portion of the housing in the retracted position, and theshielding portion of the shield may extend from the interior portion ofthe housing in the extended position. The interior portion of thehousing may be circumferentially disposed about a specimen collectioncontainer receiving port defined within the housing, and the interiorportion of the housing may be co-axial with the specimen collectioncontainer receiving port.

Optionally, the housing may include a first portion and a secondportion, with the first portion distal to the second portion. The shieldmay be entirely disposed within an interior of the first portion in theretracted position, and a specimen collection container receiving portmay be defined within the second portion. The first portion and thesecond portion of the housing may be co-formed. Alternatively, the firstportion and the second portion of the housing may be separately formedand subsequently assembled. The first portion of the housing may definean observation window through which the shield is visible when in theretracted position.

In certain configurations, the shield may be biased against a portion ofthe housing by a spring when the shield is in the retracted position.The needle assembly may also include a release element transitionablefrom a first position to a second position, wherein the spring biasesthe shield to the extended position upon transition of the releaseelement from the first position to the second position. The releaseelement may be a push button. Optionally, the push button includes amember oriented in a substantially perpendicular orientation withrespect to a transition axis of the shield. The member may also extendthrough at least a portion of the shield to maintain the shield againstthe bias of the spring in the first position. The member may alsoinclude a restraining portion and may define a passage region. Therestraining portion may engage a shoulder of the shield in therestrained position, and the shoulder of the shield may pass through thepassage region upon transition from the retracted position to theextended position. In one configuration, the passage region defines asubstantially circular opening. Alternatively, the passage regiondefines a non-enclosed region. The needle assembly may also include ahub supporting at least a portion of the cannula, and the member of thepush button may define an interior region at least partially surroundinga portion of the hub.

In another configuration, the needle assembly may also include aremovable cannula guard engageable with a portion of the housing, andremovable prior to transition of the shield from the retracted positionto the extended position. A portion of the removable cannula guard mayprevent transition of the release element from the first position to thesecond position. In another configuration, at least one of a distalportion of the housing and a proximal portion of the shield may includea barrier mechanism for preventing transition of the shield from theextended position to the retracted position. The barrier mechanism mayinclude a tamper-resistant flange. The barrier mechanism may alsoinclude a locking tab deflectable upon transition of the shield from theretracted position to the extended position, which substantially resistsdeflection once the shield is in the extended position. A portion of thehousing may surround at least a portion of the locking tab. The portionof the housing surrounding the locking tab may substantially resistdeflection of the locking tab.

The shield of the needle assembly may include a first portion forslideably engaging a portion of the housing along a longitudinal axis ofthe cannula, and a second portion at least partially surrounding aportion of the cannula in the extended position. The first portion ofthe shield may slideably engage an outer surface of the housing. In oneconfiguration, the first portion of the shield includes a protrusion forslideably engaging a groove recessed within a portion of the outersurface of the housing. In another configuration, a glide mechanismincludes a portion of the housing and portion of the first portion ofthe shield, wherein a portion of the safety shield is axiallytransitionable with respect to a portion of the housing.

The needle assembly may also include a hub disposed at least partiallywithin a portion of the housing, such that the first portion of theshield slideably engages a portion of the hub along a longitudinal axisof the cannula. A first end of the first portion of the shield mayslideably engage a portion of the hub, and a second end of the firstportion may extend at least partially through a portion of an outersurface of the housing. The second end of the first portion may extendat least partially through a groove defined in the outer surface of thehousing and extending along the longitudinal axis of the cannula. Inanother configuration, the second portion of the shield may surround atleast a portion of the cannula.

The shield of the needle assembly may be transitioned from the retractedposition to the extended position by force applied to the first portionof the shield in the direction along a longitudinal axis of the cannula.The second portion of the shield may also include restraining means forpreventing transition of the shield from the extended position to theretracted position.

In one configuration, the second portion of the shield includes adepending arm transitionable from a first position in which thedepending arm is substantially perpendicular to a longitudinal axis ofthe cannula, to a second position in which the depending arm is orientedsubstantially along the longitudinal axis of the cannula. The dependingarm may include a first portion and a second portion, with the firstportion and the second portion pivotally or hingedly connected to thefirst portion. The shield may include a depending arm, including aplurality of extendable segments, wherein the extendable segments aresubstantially laterally oriented in the retracted position andsubstantially longitudinally oriented in the extended position. Theplurality of extendable segments may be pivotally or hingedly connectedtherebetween. The depending arm may be oriented on a first side of thecannula, and a second depending arm may be oriented on a second side ofthe cannula, with the second side being substantially opposite the firstside.

In another embodiment of the present invention, a blood collectionassembly includes a housing including a flash chamber, the housinghaving a distal end and a proximal end, and a blood collection containerholder adjacent the proximal end. The blood collection assembly includesa patient cannula having a cannula tip and defining a patient cannulainterior. The patient cannula projecting at least partially from thedistal end of the housing, and the patient cannula interior is in fluidcommunication with the flash chamber. The blood collection assembly alsoincludes a non-patient cannula, defining a non-patient cannula interior,extending in a substantially proximal direction from the patient cannulawithin at least a portion of the blood collection container holder. Thenon-patient cannula interior is in fluid communication with the flashchamber. The blood collection assembly also includes a shieldrestrainably engaged with a portion of the housing. The shield isaxially transitionable over the patient cannula from a retractedposition in which the patient end is exposed, to an extended position inwhich the cannula tip is shielded by at least a portion of the shield.At least a portion of the flash chamber is visible in the retractedposition.

The flash chamber may be visible through at least a portion of theshield in the retracted position. The blood collection assembly mayfurther include a removable or rupturable seal disposed over at least aportion of the blood collection container holder. In one configuration,the shield may be biased against a portion of the housing by a spring inthe retracted position. The blood collection assembly may furtherinclude a release element transitionable from a first position to asecond position, wherein the spring transitions the shield to theextended position upon transition of the release element from the firstposition to the second position. The shield may also include a firstportion for slideably engaging a portion of the housing along thelongitudinal axis of the patient cannula, and a second portion at leastpartially surrounding a portion of the patient cannula in the extendedposition.

In yet another embodiment of the present invention, a needle assemblyincludes a housing having a flash chamber, the housing having a distalend, and a proximal end engageable with a specimen collection container.The needle assembly includes a cannula having a patient end, anon-patient end, and a sidewall extending therebetween defining acannula interior. The patient end of the cannula projects at leastpartially from the distal end of the housing, and the cannula interioris in fluid communication with the flash chamber. The needle assemblyalso includes a shield restrainably engaged with a portion of thehousing. The shield is axially transitionable over the patient cannulafrom a retracted position in which the patient end is exposed, to anextended position in which the patient end is shielded by at least aportion of the shield. At least a portion of the flash chamber isvisible in the retracted position. The needle assembly also includes aspring element biased between a portion of the housing and a portion ofthe shield in the retracted position. The needle assembly furtherincludes a release element transitionable from a first position to asecond position. The release element restrains the shield against thebias of the spring in the restrained position, and transition of therelease element from the first position to the second positiontransitions the shield from the retracted position to the extendedposition.

The release element may be a push button. In certain configurations, atleast a portion of the flash chamber is visible through a portion of theshield in the retracted position. In other configurations, the proximalend of the housing includes a blood collection container holder, and thenon-patient end of the cannula extends at least partially within aninterior of the blood collection container holder.

In another embodiment of the present invention, a blood collectionassembly includes a housing having a flash chamber, the housing having adistal end and a proximal end, and a blood collection container holderadjacent the proximal end. The blood collection assembly includes apatient cannula having a cannula tip and defining a patient cannulainterior. The patient cannula projects at least partially from thedistal end of the housing, and the patient cannula interior is in fluidcommunication with the flash chamber. The blood collection assembly alsoincludes a non-patient cannula, defining a non-patient cannula interior.The non-patient cannula extends in a substantially proximal directionfrom the patient cannula within at least a portion of the bloodcollection container holder. The non-patient cannula interior is influid communication with the flash chamber. The blood collectionassembly also includes a shield restrainably engaged with a portion ofthe housing. The shield is axially transitionable over the patientcannula from a retracted position in which the cannula tip is exposed,to an extended position in which the cannula tip is shielded by at leasta portion of the shield. At least a portion of the flash chamber isvisible through the shield in the retracted position. The bloodcollection assembly also includes a spring element biased between aportion of the shield and a portion of the housing in the retractedposition. The blood collection assembly further includes a push buttonengaged with a portion of the spring, and transitionable from a firstposition to a second position. The spring transitions the shield to theextended position upon transition of the release element from the firstposition to the second position.

In yet another embodiment of the present invention, a blood collectionassembly includes a housing having a flash chamber, the housing having adistal end, and a proximal end engageable with a specimen collectioncontainer. The blood collection assembly includes a cannula having apatient end, a non-patient end, and a sidewall extending therebetweendefining a cannula interior. The patient end of the cannula projects atleast partially from the distal end of the housing, and the cannulainterior is in fluid communication with the flash chamber. The bloodcollection assembly also includes a shield, having an observationwindow, and engaged with a portion of the housing. The shield istransitionable from a first position to a second position with respectto the housing, wherein the shield is disposed over the patient end inthe second position, and wherein at least a portion of the flash chamberis viewable through the observation window in the first position.

The shield may be axially transitionable over the cannula from aretracted position to an extended position. Alternatively, the shieldmay be pivotally transitionable over the patient cannula from aretracted position to an extended position.

In yet another embodiment of the present invention, a blood collectionassembly include a housing having a flash chamber, the housing having adistal end, and a proximate end engageable with a specimen collectioncontainer. The blood collection assembly includes a cannula having apatient end, a non-patient end, and a sidewall extending therebetweendefining a cannula interior. The patient end of the cannula projects atleast partially from the distal end of the housing, and the cannulainterior is in fluid communication with the flash chamber. The bloodcollection assembly also includes a shield engaged with a portion of thehousing. The shield is transitionable from a first position to a secondposition with respect to the housing. The flash chamber is visible inthe first position, and the shield is disposed over the patient end ofthe cannula in the second position. The locking structure engages atleast a portion of the flash chamber in the second position. In oneconfiguration, the locking structure of the shield engages a portion ofthe housing distal to the flash chamber.

In one embodiment, the housing of a needle assembly includes a baseportion having a sidewall defining an opening, and a hub portionengageable with the base portion. A portion of the hub portion may bereceivable through the opening. In another configuration, the sidewallof the base portion defines a first opening and a second opening alignedalong a common axis. The hub portion may include a first portion and asecond portion aligned along a common axis. The first portion may bereceivable through the first opening and the second portion isreceivable through the second opening. In yet another configuration, thehub portion may be insertable within an interior of the base portionthrough a proximal end of the base portion. At least one of the firstportion and the second portion may be deflectable against a portion ofan interior wall of the base portion during insertion of the hub portioninto the base portion.

In another embodiment, the housing of a needle assembly may include aforward hub portion and a rear hub portion connectable with the forwardhub portion, and defining the flash chamber therebetween. The rear hubportion may be connectable with the forward hub portion through at leasta portion of a specimen collection container holder. Alternatively, therear hub portion may define a specimen collection container receivingport therein.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a needle assembly having a safety shieldin the retracted position in accordance with an embodiment of thepresent invention.

FIG. 2 is a perspective view of the needle assembly of FIG. 1 having asafety shield in the extended position.

FIG. 3 is an enlarged perspective view of the push button element of aneedle assembly in accordance with an embodiment of the invention.

FIG. 4 is an enlarged perspective view taken from section 4 of FIG. 2,showing the channel of the safety shield in accordance with anembodiment of the invention.

FIG. 5 is a side view of the needle assembly of FIG. 1 having a safetyshield in the retracted position.

FIG. 6 is a side view of the needle assembly of FIG. 2 having a safetyshield in the extended position.

FIG. 7 is a side cross-sectional view of the needle assembly of FIG. 1having a safety shield in the retracted position.

FIG. 8 is a side cross-sectional view of the needle assembly of FIG. 2having a safety shield in the extended position.

FIG. 9 is a top cross-sectional view of the needle assembly of FIG. 1having a safety shield in the retracted position and showing a lockingmechanism in accordance with an embodiment of the present invention.

FIG. 10 is a top cross-sectional view of the needle assembly of FIG. 2having a safety shield in the extended position and showing a lockingmechanism.

FIG. 11 is a perspective view of a needle assembly having a flashchamber in accordance with a further embodiment of the presentinvention.

FIG. 12 is a rear perspective view of the needle assembly having a flashchamber of FIG. 11.

FIG. 13 is an exploded view of the needle assembly having a flashchamber of FIG. 11.

FIG. 14A is a cross-sectional view of the needle assembly having a flashchamber of FIG. 11.

FIG. 14B is an enlarged cross-sectional view of a portion of the needleassembly of FIG. 14A.

FIG. 15A is a cross-sectional view of a needle assembly having a flashchamber used in connection with a blood collection assembly in yet afurther embodiment.

FIG. 15B is an enlarged sectional view of a portion of the needleassembly of FIG. 15A.

FIG. 16 is a perspective view of a needle assembly having a safetyshield in the retracted position and a needle cover in accordance withan embodiment of the present invention.

FIG. 17 is a perspective view of the needle assembly of FIG. 16 with theneedle cover removed and having a safety shield in the extendedposition.

FIG. 18 is a side view of the needle assembly of FIG. 16 having a safetyshield in the retracted position and with a needle cover.

FIG. 19 is a side view of the needle assembly of FIG. 17 with the needlecover removed and having a safety shield in the extended position.

FIG. 20 is a side cross-sectional view of the needle assembly of FIG. 16having a safety shield in the retracted position and with a needlecover.

FIG. 21 is a side cross-sectional view of the needle assembly of FIG. 17with the needle cover removed and having a safety shield in the extendedposition.

FIG. 22 is a top cross-sectional view of the needle assembly of FIG. 16having a safety shield in the retracted position with a needle cover andshowing a locking mechanism in accordance with an embodiment of thepresent invention.

FIG. 23 is a top cross-sectional view of the needle assembly of FIG. 17with the needle cover removed and having a safety shield in the extendedposition and showing a locking mechanism.

FIG. 24 is a perspective view of the needle assembly of the presentinvention, with the safety shield removed for illustration purposes andincluding a needle cover in accordance with an embodiment of the presentinvention.

FIG. 25 is a cross-sectional view of the needle assembly of FIG. 24.

FIG. 26 is a perspective view of the holder portion of the needleassembly of an embodiment of the present invention having the pushbutton in the unengaged retracted position.

FIG. 27 is a perspective view of the holder shown in FIG. 26 having thepush button in the engaged extended position.

FIG. 28 is a perspective view of an embodiment of the push button inaccordance with the present invention.

FIG. 29 is a perspective view of a needle assembly having a safetyshield in the retracted position in accordance with a further embodimentof the present invention.

FIG. 30 is a perspective view of the needle assembly of FIG. 29 having asafety shield in the extended position.

FIG. 31 is a side view of the needle assembly of FIG. 29 having a safetyshield in the retracted position.

FIG. 32 is a side view of the needle assembly of FIG. 30 having a safetyshield in the extended position.

FIG. 33 is a top-down cross-sectional view of the needle assembly ofFIG. 29 having a safety shield in the retracted position.

FIG. 34 is a top-down cross-sectional view of the needle assembly ofFIG. 30 having a safety shield in the extended position.

FIG. 35 is a perspective view of FIG. 29 showing the front-section of aportion of the needle holder.

FIG. 36 is a perspective view of the push button of the needle assemblyshown in FIG. 29.

FIG. 37 is a perspective view of the needle assembly of FIG. 29 having aneedle shield in accordance with an embodiment of the present invention.

FIG. 38 is a cross-sectional view of the needle assembly shown in FIG.29 having a removable cannula guard disposed thereon.

FIG. 39 is a perspective view of a needle assembly with a push buttonactivator having a removable cannula guard covering a safety shield inthe retracted position in accordance with an embodiment of the presentinvention.

FIG. 40 is a perspective view of the needle assembly of FIG. 39 havingthe removable cannula guard removed showing the safety shield in theextended position.

FIG. 41 is a side view of the needle assembly of FIG. 39.

FIG. 42 is a side view of the needle assembly of FIG. 40.

FIG. 43 is a cross-sectional view of the needle assembly of FIG. 39.

FIG. 44 is a cross-sectional view of the needle assembly of FIG. 40.

FIG. 45 is a top view of the needle assembly of FIG. 39.

FIG. 46 is a top view of the needle assembly of FIG. 40.

FIG. 47 is a cross-sectional view of the needle assembly of FIG. 39.

FIG. 48 is a cross-sectional view of the needle assembly of FIG. 40.

FIG. 49 is a close-up cross-section view of the needle assembly of FIG.47.

FIG. 50 is an exploded perspective view of the needle assembly of FIG.39.

FIG. 51 is a partial perspective side view of a locking tab inaccordance with an embodiment of the present invention.

FIG. 52 is a partial perspective side view of the locking tab of FIG. 51partially engaged with a housing in accordance with an embodiment of thepresent invention.

FIG. 53 is an exploded perspective view of a needle assembly inaccordance with an embodiment of the present invention.

FIG. 54 is a partially assembled perspective view of the needle assemblyof FIG. 53.

FIG. 55 is a partially assembled perspective view of the needle assemblyof FIG. 53.

FIG. 56 is an alternative exploded perspective view of a needle assemblyin accordance with an embodiment of the present invention

FIG. 57 is a partially assembled perspective view of the needle assemblyof FIG. 56.

FIG. 58 is a partially assembled perspective view of the needle assemblyof FIG. 56.

FIG. 59 is a perspective view of a needle assembly having a distalneedle shield, and proximal needle shield in accordance with anembodiment of the present invention.

FIG. 60 is a top view of the hub assembly, distal needle shield, andproximal needle shield of FIG. 59.

FIG. 61 is a cross-sectional top view of the needle assembly of FIG. 60.

FIG. 62 is a side view of the needle assembly of FIG. 59.

FIG. 63 is a cross-sectional view of the side view of FIG. 62.

FIG. 64 is a perspective view of the needle assembly of FIG. 59 engagedwith a specimen collection container holder in accordance with anembodiment of the present invention.

FIG. 65 is a cross-sectional side view of a needle assembly in theretracted position having an alternative locking mechanism in accordancewith an embodiment of the present invention.

FIG. 66 is a cross-sectional side view of the needle assembly of FIG. 65in the extended position.

FIG. 67 is a perspective view of a needle assembly having a safetyshield in the retracted position and including a glide mechanism inaccordance with an embodiment of the present invention.

FIG. 68 is a perspective view of the needle assembly of FIG. 67 having asafety shield in the extended position.

FIG. 69 is a side view of the needle assembly of FIG. 67 having a safetyshield in the retracted position.

FIG. 70 is a side view of the needle assembly of FIG. 68 having a safetyshield in the extended position.

FIG. 71 is a cross-sectional view of the needle assembly of FIG. 69having a safety shield in the retracted position.

FIG. 72 is a cross-sectional view of the needle assembly of FIG. 70having a safety shield in the extended position.

FIG. 73 is an exploded perspective view of a needle assembly with aglideable safety shield in accordance with an embodiment of the presentinvention.

FIG. 74 is an exploded perspective view of the needle assembly of FIG.73.

FIG. 75 is a top view of the needle assembly of FIG. 73 in the assembledand retracted position.

FIG. 76 is a cross-sectional top view of the needle assembly of FIG. 75in the retracted position.

FIG. 77 is a cross-sectional side view of the needle assembly of FIG. 73in the assembled and retracted position.

FIG. 78 is a side view of the needle assembly of FIG. 77 in theretracted position.

FIG. 79 is a bottom view of the needle assembly of FIG. 73 in theassembled and retracted position.

FIG. 80 is a front view of the assembled needle assembly of FIG. 73.

FIG. 81 is a rear view of the needle assembly of FIG. 80.

FIG. 82 is a cross-sectional top view of the needle assembly of FIG. 76in the extended position.

FIG. 83 is a top view of the needle assembly of FIG. 82 in the extendedposition.

FIG. 84 is a cross-sectional side view of the needle assembly of FIG. 77in the extended position.

FIG. 85 is a side view of the needle assembly of FIG. 78 in the extendedposition.

FIG. 86 is a bottom view of the needle assembly of FIG. 79 in theextended position.

FIG. 87 is a perspective view of a needle assembly having anarticulating hinge safety shield in the retracted position in accordancewith an embodiment of the present invention.

FIGS. 88-90 are perspective views of the needle assembly of FIG. 87having an articulating hinge safety shield shown in various stages ofpartial extension.

FIG. 91 is a perspective view of the needle assembly of FIG. 87 havingan articulating hinge safety shield in the fully extended position.

FIG. 92 is a perspective view of a needle assembly having a butterflyhinged safety shield in the retracted position in accordance with anembodiment of the present invention.

FIG. 93 is a perspective view of the needle assembly of FIG. 92 having abutterfly hinged safety shield shown in the extended position.

FIG. 94 is a perspective view of a needle assembly having a hingedsafety shield and a needle guard shield in accordance with an embodimentof the present invention.

FIG. 95 is a side view of the needle assembly of FIG. 94.

FIG. 96 is a top view of the needle assembly of FIG. 94.

FIG. 97 is a cross-sectional side view of the needle assembly of FIG.94.

FIG. 98 is a perspective view of the needle assembly of FIG. 94 havingthe needle guard shield removed and in the retracted position.

FIG. 99 is a side view of the needle assembly of FIG. 98.

FIG. 100 is a top view of the needle assembly of FIG. 98.

FIG. 101 is a cross-sectional side view of the needle assembly of FIG.98.

FIG. 102 is a perspective view of the needle assembly of FIG. 98 in theextended position.

FIG. 103 is a side view of the needle assembly of FIG. 102.

FIG. 104 is a cross-sectional view of the needle assembly of FIG. 102.

FIG. 105 is a perspective view of the engagement of the safety shieldand the front hub portion in accordance with an embodiment of thepresent invention.

FIG. 106 is a close-up sectional perspective view of the engagementbetween the safety shield and the front hub portion in accordance withan embodiment of the present invention.

FIG. 107 is an exploded perspective view of a needle assembly having ahinged safety shield in accordance with an embodiment of the presentinvention.

FIG. 108 is an assembled perspective view of the needle assembly of FIG.107 in the retracted position.

FIG. 109 is a side view of the needle assembly of FIG. 108.

FIG. 110 is a top view of the needle assembly of FIG. 108.

FIG. 111 is a cross-sectional side view of the needle assembly of FIG.108.

FIG. 112 is a front view of the needle assembly of FIG. 108.

FIG. 113 is a rear view of the needle assembly of FIG. 108.

FIG. 114 is a cross-sectional side view of the needle assembly of FIG.108.

FIG. 115 is an alternative exploded view of a needle assembly having ahinged safety shield in accordance with an embodiment of the presentinvention.

FIG. 116 is a perspective view of the needle assembly of FIG. 108 in theextended position.

FIG. 117 is a top view of the needle assembly of FIG. 116 in theextended position.

FIG. 118 is a cross-sectional side view of the needle assembly of FIG.116.

FIG. 119 is a side view of the needle assembly of FIG. 116 in theextended position.

FIG. 120 is a front view of the needle assembly of FIG. 116.

FIG. 121 is a rear view of the needle assembly of FIG. 116.

FIG. 122 is a sectional perspective view of an alternative hinged safetyshield shown in the extended position in accordance with an embodimentof the present invention.

FIG. 123 is a perspective view of a needle assembly having a pierceableseal prior to use with a sample container in accordance with anembodiment of the present invention.

FIG. 124 is a perspective view of the needle assembly of FIG. 123 inuse.

FIG. 125 is a perspective view of the needle assembly of FIG. 124 havingthe container removed from the pierceable seal after use.

FIG. 126 is a perspective view of a base portion of the housing of aneedle assembly in accordance with an embodiment of the presentinvention.

FIG. 127 is a side view of the base portion of FIG. 126.

FIG. 128 is a perspective view of a hub portion of the housing of aneedle assembly in accordance with an embodiment of the presentinvention.

FIG. 129 is a side view of the hub portion of FIG. 128.

FIG. 130 is a perspective view of an assembled housing of a needleassembly including the base portion of FIG. 126 and the hub portion ofFIG. 128.

FIG. 131 is a side view of the assembled housing of FIG. 130.

DETAILED DESCRIPTION

In general, the needle assembly of the present invention allows foraccess of a patient's vasculature by a needle cannula, visual indicationof vasculature access, and subsequent safety shielding of the needlecannula to protect medical practitioners.

In one embodiment of the present invention, a needle assembly 30 isprovided, as generally shown in FIGS. 1-10. The needle assembly 30generally includes a housing 32 having a flash chamber 38 integraltherewith, a cannula 34 associated with the housing 32, and a safetyshield 36 adapted to transition from a retracted position, shown in FIG.1, to an extended position, shown in FIG. 2, for safety shielding of thecannula 34 during and/or after use of the needle assembly 30. The needleassembly 30 is shown in the retracted position ready for use in aspecimen collection procedure, such as a blood collection procedure, inFIG. 1, and after use in the extended position shielding the cannula inFIG. 2.

With particular reference to FIGS. 7-10, the needle assembly 30 includesa cannula 34 having a distal patient end 40 and a proximal non-patientend 42. It will be noted that the term “distal” as used herein, refersgenerally to the forward end of the needle assembly 30 that is adaptedto puncture the skin of a patient and access the patient's vasculature,while the term “proximal” refers generally to the rear end of the needleassembly 30 that is engageable with a specimen collection container(shown in FIG. 123). The cannula 34 includes a sidewall 48 extendingbetween the patient end 40 and the non-patient end 42 and defining acannula interior 50. In one embodiment, the cannula 34 may include atleast two distinct needles, such as a distal patient needle 52 and aproximal non-patient needle 54, both of which define a common centrallumen within the cannula interior 50. In a further embodiment, thedistal patient needle 52 is aligned substantially along a common axiswith the proximal non-patient needle 54 and separated from the proximalnon-patient needle 54 by a break 56. The proximal non-patient end 42 ofthe cannula 34 is provided for puncturing a specimen collectioncontainer (shown in FIG. 123). In one embodiment, the proximalnon-patient end 42 of the cannula 34 may be covered by a pierceableelastomeric multiple sample sleeve 60. The distal patient end 40 mayhave a bevel for allowing easier penetration of a patient's skin.

The cannula 34 of the needle assembly may be at least partiallysupported by a portion of the housing 32. In one embodiment, the housing32 may be a hub 64 for supporting a portion of the cannula 34. Forexample, proximal non-patient needle 54 and distal patient needle 52 maybe affixed or otherwise adhered within a central opening 66 of the hub64, with a break 56 present between proximal non-patient needle 54 andthe distal patient needle 52. In another configuration, the hub 64 maybe formed of separate elements. For example, a proximal or rear hubportion 68 may be connected with or affixed to a forward hub portion 70,thereby forming the hub 64 as a unitary structure, with the cannula 34extending therethrough.

As shown in FIGS. 1-2 and 5-10, the housing 32 may have a distal end 74and a proximal end 72 engageable with a specimen collection container(shown in FIG. 123). As used herein, the phrase “engageable with aspecimen collection container” means that a specimen collectioncontainer may be attached to or affixed with a portion of the proximalend 72 of the housing 32, or that a specimen collection container may bepassed within or disposed over or about a portion of the proximal end 72of the housing 32 and secured to another portion of the housing 32. Inone embodiment, the proximal end 72 of the needle assembly 30 may definea specimen collection container receiving port 76, adapted to receive aspecimen collection container (shown in FIG. 123) therewith.

In another embodiment, the needle assembly 30 is a specimen collectionassembly, such as a blood collection assembly, in which the housing 32of the needle assembly 30 includes a specimen collection containerholder 78 adjacent the proximal end 72 of the needle assembly 30. Thespecimen collection container holder 78 includes a proximal end 80, adistal end 82, and a tubular sidewall 84 extending therebetween. In oneembodiment, the specimen collection container holder 78 may include asecond tubular sidewall 86 circumferentially disposed about the tubularsidewall 84. The proximal end 80 of the specimen collection containerholder 78 may be substantially open at opening 88 and may be adapted toreceive a specimen collection container (shown in FIG. 123) therein. Theproximal end 80 may also have a radially aligned flange 90 to facilitatemanipulation of the needle assembly 30. The flange 90 may benon-circular to prevent the needle assembly 30 from rolling, or forother purposes such as communicating to the user the intendedorientation of the needle assembly 30.

The specimen collection container holder 78 is adapted to accommodate atleast a portion of the cannula 34 in a mating relationship. For example,the distal end 82 of the specimen collection container holder 78 mayinclude an engagement portion 92 to which a portion of the cannula 34,such as the non-patient end 42 is mounted through a portion of the hub64. In particular, the distal end 82 of the specimen collectioncontainer holder 78 may include an engagement portion 92 having a matingstructure, such as a threaded engagement, adapted to receive the rearhub portion 68 of the hub 64. In one embodiment, the engagement portion92 can include threads 94 for engagement with corresponding threads 96of the rear hub portion 68 of hub 64. Other mating relationships arealso contemplated herein, such as mating male and female luer assemblycomponents. The hub 64 may be also adhesively affixed to the engagementportion 92 of the specimen collection container holder 78. In anotherembodiment, the hub 64 may be press-fit or snapped into the specimencollection container holder 78. Alternatively, hub 64 may be integrallyformed with the distal end 82 of the specimen collection containerholder 78, providing a mechanism for direct attachment of the cannula 34to the specimen collection container holder 78. In certain embodiments,the cannula 34 is joined with a portion of the specimen collectioncontainer holder 78 by the manufacturer so that the device is ready forfast and convenient use by the medical practitioner.

In certain configurations, the patient end 40 of the cannula 34 projectsat least partially from the distal end 74 of the housing 32, and thenon-patient end 42 extends in a substantially proximal direction fromthe patient end 40. In another embodiment, the distal patient needle 52projects at least partially from the distal end 74 of the housing 32,and the proximal non-patient needle 54 extends in a substantiallyproximal direction from the patient needle.

At least a portion of the housing 32, including the hub 64, the specimencollection container holder 78, and the second tubular sidewall 86,includes a flash chamber 98. As used herein, the term “flash chamber”includes a cavity into which a specimen, such as blood, from a patientmay pass, and through which the presence of the specimen within thecavity may be visibly detected by a medical practitioner. The flashchamber 98 may be integrally formed with a portion of the housing 32 or,alternatively, may be separately formed and subsequently engaged with aportion of the housing 32. In one embodiment, the cannula interior 50 isin fluid communication with the flash chamber 98. In a furtherembodiment, the sidewall 48 of the cannula may define an openingextending between the cannula interior 50 and the flash chamber 98 topermit the flow of a specimen, such as blood, from the cannula 34 to theflash chamber 98. In another embodiment, the cannula 34 includes adistal patient needle 52 in fluid communication with the flash chamber98, and a proximal non-patient needle 54 in fluid communication with theflash chamber 98. Accordingly, when the distal patient needle 52 isprovided access with a patient's vasculature, blood may flow from thepatient through the distal patient needle 52 and into the flash chamber98. When the proximal non-patient needle 54 is engaged with an evacuatedspecimen collection container (not shown), blood may flow from the flashchamber 98 and through the proximal non-patient needle.

In one embodiment, the hub 64 may include an interior 100 between aportion of the rear hub portion 68 and a portion of the forward hubportion 70. A flash chamber 98 may be formed within at least a portionof the interior 100 of the hub 64. In one configuration, the hub 64, orat least a portion of the hub 64, such as the forward hub portion 70,may be constructed from a transparent or translucent material, such as apolymeric material or resin. Alternatively, a flash chamber 98 may beintegrally formed within another portion of the housing 32, such asintegrally formed with the specimen collection container holder 78, orwithin a portion of a secondary tubular sidewall 86.

In use, blood flow from a patient through the cannula 34 will enter theflash chamber 98 through the opening 88 in the cannula 34, therebypartially filling the flash chamber 98 with blood. The flash chamber 98provides a visual mechanism for recognition of venous access to amedical practitioner. Example flashback indicators are described, forexample, in United States Patent Publication No. 2005/0004524, theentire disclosure of which is herein incorporated by reference.

The needle assembly 30 further includes a safety shield 36, whichprovides a mechanism to shield the cannula 34, and in particular thepuncture tip at the patient end 40, after use thereof. At least aportion of the safety shield 36 is restrainably engaged with a portionof the housing 32 and transitionable from a retracted position, as shownin FIGS. 1, 5, 7, and 9, to an extended position, as shown in FIGS. 2,6, 8, and 10. The safety shield 36 may be transitionable from theretracted position to the extended position over a portion of thecannula 34. In one embodiment, the safety shield 36 is axiallytransitionable over the cannula 34. In a further embodiment, the safetyshield 36 is axially transitionable over the cannula 34 from a retractedposition, in which at least the puncture tip of the patient end 40 ofthe cannula 34 is exposed, such as for accessing a patient, to anextended position, in which at least the puncture tip of the patient end40 of the cannula 34 is shielded by at least a portion of the safetyshield 36. As used herein, the phrase “shielded by at least a portion ofthe safety shield” means that accidental contact with the puncture tipat the patient end 40 of the cannula 34 is prevented by the position ofat least a portion of the safety shield in shielding orientation withrespect to the patient end 40 of the cannula 34. In one embodiment, thesafety shield 36 at least partially surrounds or encompasses the patientend 40 of the cannula 34 in the extended position.

In one embodiment, as shown specifically in FIGS. 5-10, the shield 36may be disposed within an interior portion 106 of the housing 32, suchas between the sidewall 84 and the second sidewall 86 of the housing 32,in the retracted position. For example, the safety shield 36 may bedisposed between a sidewall 84 forming a portion of the specimencollection container holder 78 and a second sidewall 86 disposed aboutthe sidewall 84. The safety shield 36 may have any suitable dimensionsand configuration such that it is adapted to shield the puncture tip ofthe patient end 40 of the cannula 34 when the safety shield 36 isactuated to extend to the extended position, as shown in FIG. 2. In oneembodiment, transition of the safety shield 36 from the retractedposition to the extended position may be initiated once the puncture tipof the patient end 40 of the cannula 34 has been removed from thepatient. In another embodiment, transition of the safety shield 36 fromthe retracted position to the extended position, may be initiated whilethe cannula 34 is in communication with the body of a patient, such aswhile the patient end 40 of the cannula 34 is in fluid communicationwith the vasculature of a patient. Accordingly, the safety shield 36 maybe deployed over the cannula 34 while the cannula 34 is accessing theinterior of the patient's blood vessel (not shown), or after the cannula34 has been removed from the patient. If the transition of the safetyshield 36 from the retracted position to the extended position occurswhile the cannula 34 is accessing the interior of a patient's bloodvessel, the distal portion 102 of the safety shield 36 will contact thepatient's skin.

In one embodiment, the shield 36 includes a shielding portion 104 whichis axially moveable in the direction of the longitudinal axis A of thecannula 34, shown in FIG. 5, from the retracted position to the extendedposition. The shielding portion 104 may be restrainably engaged withinthe interior portion 106 of the housing 32 in the retracted position,and the shielding portion 104 may extend from the interior portion 106of the housing 32 in the extended position. In one embodiment, axialtransition of the shield 36 from the retracted position to the extendedposition transitions the shielding portion 104 from within the interiorportion 106 of the housing 32 to a location at least partially exteriorto the housing 32 substantially along the longitudinal axis A of thecannula 34. In another embodiment, the interior portion 106 of thehousing 32 may be circumferentially disposed about the specimencollection container holder 78 or specimen collection containerreceiving port 76. In yet another embodiment, the interior portion 106of the housing 32 is co-axial with the specimen collection containerholder 78 or specimen collection container receiving port 76. As usedherein, the term “co-axial” includes orientations in which the interiorportion 106 and the specimen collection container holder 78 or specimencollection container receiving port 76 are each disposed about thelongitudinal axis A of the cannula 34. In a further embodiment, thesafety shield 36 is disposed about at least a portion of the cannula 34,and transition of the safety shield 36 from the retracted position tothe extended position telescopes the safety shield 36 over a portion ofthe cannula 34. Optionally, the safety shield 36 may be substantiallycircumferentially disposed about at least a portion of the cannula 34.It is also contemplated herein that the safety shield 36 may include asingle telescoping portion, such as shielding portion 104, or mayinclude multiple circumferentially disposed nesting segments that areeach transitionable over the cannula 34.

The safety shield 36 may be deployed by a release member 108, such as apush button, transitionable from a first position to a second position.The release member 108 may be deployable through an exterior surface 110of the safety shield 36 and housing 32. In one embodiment, the releasemember 108 may actuate the transition of the safety shield 36 from theretracted position to the extended position. In another embodiment, therelease member 108 may initiate an activator to transition the safetyshield 36 from the retracted position to the extended position. In theembodiment depicted in FIGS. 1-10, the release member 108 includes amember 112, such as an arm, oriented in a substantially perpendicularorientation with respect to the transition axis T of the safety shield36, shown in FIG. 6. As used herein, the phrase “transition axis”includes the orientation of the shield during transition from theretracted position to the extended position. In certain embodiments, thetransition axis is aligned with the longitudinal axis A of the cannula34. The member 112 may be connected to a restraining portion 114, suchas an enlarged body, creating a passage region 116, such as a narrowedneck, as shown in FIG. 3. In one embodiment, the passage region 116defines a non-enclosed region, such as an indentation or a cut-awayportion. The restraining portion 114 of the release member 112 furtherincludes a shoulder 118 adjacent the passage region 116. Further, asshown in FIG. 3, safety shield 36 includes an elongated channel 120extending through the shield 36, with an enlarged opening adjacent theforward or distal end thereof, creating a stop surface shoulder 122adjacent the forward edge of the channel 120. In one embodiment, theelongated channel 120 extends longitudinally through the shield 36 alonga top surface thereof.

With the safety shield 36 in the retracted position as shown in FIG. 1,the release member 108 is in a first position, with the restrainingportion 114 extending into the shield 36, and with the stop surfaceshoulder 122 in an abutting engagement with the shoulder 118 of therelease member 108, thereby preventing movement of the safety shield 36in a forward or distal direction. When release member 108, such as apush button, is transitioned from the first position, such as depressedin the direction of arrow A in FIG. 3, the restraining portion 114 movesin a substantially downward orientation with respect to safety shield36, thereby releasing the abutting engagement between stop surfaceshoulder 122 and the shoulder 118. As such, the sidewall 124 of thesafety shield 36 adjacent elongated channel 120 can guide through thepassage region 116 of the release member 108 unobstructed, therebypermitting safety shield 36 to transition from the retracted positionshown in FIG. 1 to the extended position shown in FIG. 2. Accordingly,the restraining portion 114 of the release member 108 engages a stopsurface shoulder 122 of the shield 36 in the restrained position, andthe stop surface shoulder 122 of the shield 36 passes through thepassage region 116 of the release member 108 upon transition of therelease member from a first position to a second position and transitionof the shield 36 from the restrained position to the extended position.

In one embodiment, the safety shield 36 may be biased toward theextended position by a spring 126 disposed between a portion of thesafety shield 36 and a portion of the housing 32. The safety shield 36may be biased toward the extended position by the spring 126 when theshield 36 is in the retracted position. In one embodiment, the spring126 may be disposed between a proximal portion 128 of the safety shield36 and a proximal end 72 of the housing 32. In another embodiment, asshown in FIGS. 7-10, the spring 126 may be disposed between the sidewall84 of the housing 32 and the second sidewall 86. Upon transition of therelease member 108 from the first position to the second position, theabutting engagement between the stop surface shoulder 122 and theshoulder 118, shown in FIG. 3, is released and the spring 126 biases thesafety shield 32 to the extended position thereby safely shielding thecannula 32.

As shown in FIGS. 9-10, the safety shield 36 may further be providedwith a barrier mechanism 130 structured to prevent the safety shield 36from transitioning from the extended position to the retracted positiononce the safety shield 36 has been transitioned from the retractedposition to the extended position. Accordingly, the barrier mechanism130 prevents re-entry of the shield 36 into the housing 32 and exposureof cannula 34 after it has been shielded. In the embodiment, at leastone of the distal end 74 of the housing 32 and the proximal portion 128of the shield 36 include a barrier mechanism 130. In another embodiment,both the distal end 74 of the housing 32 and the proximal portion 128 ofthe shield 36 include a barrier mechanism 130.

The barrier mechanism 130 may include a restraint 132 and a break 134.The break 134 may include a slanted distal portion 136 and a proximalportion 138 having a plane substantially perpendicular to a portion ofthe safety shield 36. The break 134 is sized to allow passage beyond therestraint 132 included within the distal end 74 of the housing 32 whenthe safety shield 36 is transitioned from the restrained position to theextended position. The proximal portion 138 of the break 134 is alsodimensioned to restrain the safety shield 36 against the restraint 132to resist passage of the safety shield 36 past the restraint 132 oncethe shield 36 is transitioned from the retracted position to theextended position. In another embodiment, the release member 108 may beat least partially restrained by a portion of the shield 36, such thatthe shield 36 cannot be reset after transitioning from the retractedposition to the extended position.

As shown in FIGS. 1, 5, 7, and 10, the flash chamber 98 is at leastpartially visible to a medical practitioner when the safety shield 36 isin the retracted position. In one embodiment, at least a portion of theflash chamber 98 extends beyond the distal portion 102 of the safetyshield 32 in the retracted position. In another embodiment, at least aportion of the flash chamber 98 is visible through at least a portion ofthe shield 36 in the retracted position. In another embodiment, at leasta portion of the shield 36 through which the flash chamber 98 is visiblemade of a translucent or transparent material.

As shown in FIGS. 11-15B, an alternative flash chamber, such asdescribed in United States Publication No. 2006/0036219, filed Aug. 16,2004, and U.S. application Ser. No. 12/044,354, filed Mar. 7, 2008, theentire disclosure of each of which is herein incorporated by reference,may be employed within the present invention.

In addition to conventional flash chambers which may include a ventmechanism in communication with an external environment surrounding theneedle assembly, it is also contemplated herein that a needle assemblymay include a flash chamber having a vent plug which seals upon flow ofblood into the flashback chamber, thereby inhibiting any pressurized airthat may build up within the chamber, from moving in a reverse directiontoward the inlet of the cannula. As shown in FIGS. 11-15B, it is alsocontemplated herein that a similar vent plug may be positioned withinthe housing at a location such that the vent plug divides the housinginto two chambers having sizes and dimensions to establish predeterminedvolumes thereto. Moreover, the porous vent remains porous to blood anddoes not seal upon contact with blood. Desirably, the blood does notcontact the vent plug at the initial flash indication, but such sealingoccurs at a later point during use of the assembly, as will be describedin more detail herein.

For example, as shown in FIGS. 11-14, a porous vent is positioned withinthe housing at a location such that the vent divides the housing intotwo chambers having sizes and dimensions to establish predeterminedvolumes thereto, so that the blood does not contact the porous vent forat the initial flash indication, but such contact occurs at a laterpoint during use of the assembly, as will be described in more detailherein.

As shown in FIGS. 11-14, needle assembly 410 includes a housing 412having a fluid inlet end or first end 414 and a fluid outlet end orsecond end 416. Needle assembly 410 includes exterior wall 418 definingthe housing interior. Exterior wall 418 extends generally longitudinallyat the first end 414 forming an elongate longitudinal first portion 419having a first diameter. At second end 416, exterior wall 418 forms asecond portion 421 that has a second diameter that is generally largerthan the first diameter of the first portion 419. Accordingly, housing412 may form a structure having a generally T-shaped cross-section. Theexterior wall 418 at second end 416 may be a separate element 428 thatis attachable to main body portion 430 forming housing 412, therebyassisting in manufacture and assembly of needle assembly 410. Firstportion 419 and second portion 421 may be arranged relative to eachother in a variety of arrangements, so long as they are capable offunctioning for transport of air therebetween as discussed herein.

Needle assembly 410 further includes a fluid inlet cannula 436 extendingfrom first end 414 of housing 412. Fluid inlet cannula 436 includes anexterior end 439 that defines a sharpened bevel at patient puncture tip438, and extends within first end 414 of housing 412, and may be fixedlymounted therein. Fluid inlet cannula 436 is characterized further by asubstantially cylindrical lumen extending between the ends andcommunicating with the interior of housing 412.

Needle assembly 410 also includes a non-patient puncture tip extendingfrom second end 414 of housing 412. As seen in FIG. 13, this may beaccomplished by providing needle assembly 410 with a second cannula inthe form of fluid outlet cannula 452. In particular, the end of fluidoutlet cannula 452 may define a sharpened bevel forming non-patientpuncture tip 462. Fluid outlet cannula 452 extends within second end 416of housing 412, and may be fixedly mounted therein. Fluid outlet cannula452 is characterized further by a substantially cylindrical lumencommunicating with the interior of housing 412. Fluid outlet cannula 452is mounted within housing 412 so that an interior end 464 passessubstantially coaxially therein such that fluid outlet cannula 452substantially aligns axially with the interior end of inlet cannula 436.Desirably, this is achieved by mounting fluid outlet cannula 452 at alocation adjacent second end 416 of housing 412, such that the interiorend 464 of fluid outlet cannula 452 extends within housing 412 to alocation adjacent the interior end 439 of inlet cannula 436.Additionally, the interior end 464 of fluid outlet cannula 452 is spacedonly a small distance from the interior end 439 of inlet cannula 436,thereby forming an axial gap therebetween for flow of blood into flashchamber 426 about fluid outlet cannula 452. The distance between theinterior end 464 of fluid outlet cannula 452 and the interior end 439 ofinlet cannula 436 forming the axial gap is sufficient to provide forflow of blood into the flash chamber 426 based upon the patient's bloodpressure after venipuncture. In certain embodiments, an axial gap thatis less than 0.5 mm may result in a flashback that is inconsistent.

As seen in FIG. 14B, fluid inlet cannula 436 and fluid outlet cannula452 are positioned and dimensioned within housing 412 so as to achieveboth desirable flow of blood through assembly 410 and to achieveeffective flashback indication. In particular, wall 418 of housing 412is dimensioned to provide a radial gap around fluid outlet cannula 452of about 0.2 mm at an area surrounding the internal end 464 thereof.This gap achieves a substantially laminar blood flow within flashbackchamber 426 and prevents blood hemolysis. Additionally, the small radialgap between the inner surface of wall 418 and fluid outlet cannula 452at the area surrounding the internal end 464 enables a drop of blood tobe spread thinly across the radial gap in flashback chamber 426 toprovide a magnified flashback indication with a very small volume ofblood. Thus, an easily visualized flashback indication is achievedquickly at the first appearance of blood within flashback chamber 426.It is contemplated herein that internal end 464 of outlet cannula 452may be partially supported within housing 412, so long as blood flowinto flashback chamber 426 is achieved about the internal end 464.

In an alternate arrangement, a single cannula is provided. Such anarrangement is depicted in the embodiment of FIGS. 15A-15B (shown inconnection with a blood collection assembly as will be described in moredetail herein). In such an arrangement, the fluid inlet cannula and thefluid outlet cannula represent one single cannula 470, having a patientpuncture tip 438 a non-patient puncture tip 462, and a lumen 442extending therethrough, and with the body of the cannula 470 beingfixedly attached to a portion of the housing 412 and passing entirelythrough housing 412. A portion of cannula 470 extending through housing412 includes one or more openings such as slot or aperture 444 toprovide communication between lumen 442 and flashback chamber 436 withinhousing 412. In the embodiment shown in FIGS. 15A-15B, two separateapertures 444 are shown on opposing sides of cannula 470, although it iscontemplated that any number of openings or apertures 444 can beincluded to provide for blood flow into the flash chamber 436.

Returning to the embodiment of FIGS. 11-14, needle assembly 410 furtherincludes a sealable sleeve 461 mounted to fluid outlet end 416 ofhousing 412. This may be accomplished by providing a mounting protrusion429 at second end 416 of housing 412, such as on element 428, withsealable sleeve 461 representing an elastomeric element that can befrictionally fit or otherwise affixed over protrusion 429. Sealablesleeve 461 covers non-patient puncture tip 462 at the exterior end offluid outlet cannula 452 when sealable sleeve 461 is in an unbiasedcondition. However, sealable sleeve 461 can be collapsed in response topressure exerted by the stopper of an evacuated tube for urging exteriorend 460 of fluid outlet cannula 452 through both sealable sleeve 461 andthe stopper of an evacuated tube, as known in the art.

The embodiment of FIGS. 11-14 further includes a porous vent 402positioned within the interior of housing 412. Porous vent 402 ispositioned within housing 412 to divide housing 412 into two distinctchambers, namely a first chamber represented by flashback chamber 426and a second chamber represented by secondary chamber 427. Porous vent402 may be constructed of a suitable material as described above withrespect to vent plug 900, albeit without the hydrophilic material thatswells on contact. In this manner, porous vent 402 is adapted to ventair therethrough, and represents a porous structure including aplurality of pores that allow for passage of blood therethrough. Asdiscussed in more detail herein, during use of needle assembly 410, theinternal pores within porous vent 402 at least partially fill with blooddue to the negative pressure established within secondary chamber 427.Such filled pores in combination with the negative pressure withinsecondary chamber 427 prevent air flow between the secondary chamber 427and the flashback chamber 426, and provide for fluid resistance of theblood through porous vent 402, as will be described in further detail.

Desirably, porous vent 402 is positioned within the interior of housing412 between first portion 419 and second portion 421. In this manner,first portion 419 of housing 412 essentially defines the flashbackchamber 426, and second portion 421 of housing 412 essentially definesthe secondary chamber 427. Alternatively, porous vent 402 may bepositioned within the interior of housing 412 at a location spanning thetransition between the first diameter of first portion 419 and thesecond diameter of second portion 421, as shown in the embodiment ofFIGS. 15A and 15B. In any event, porous vent 402 is generally acylindrically shaped member with a central opening therein axiallyencircling a portion of the cannula, particularly fluid outlet cannula452.

The interior volume of housing 412 is defined by the sum of the volumesof flashback chamber 426 and secondary chamber 427 as well as the volumerepresented by the pores of porous vent 402. Such interior volume isconfigured so as to provide for certain attributes to the needleassembly 410, in particular with respect to the ability of the secondarychamber 427 to be at least partially evacuated of a portion of airtherein to establish a negative pressure therein upon application of anevacuated tube to needle assembly 410 during use thereof. Such negativepressure within secondary chamber 427 draws blood through the pores ofporous vent 402 based on when blood contacts porous vent 402 andpartially fills the pores thereof. In a particular embodiment of theinvention, the overall interior volume of housing 412 may be from about300 mm³ to about 400 mm³ Such a volume is particularly useful for theintended use of needle assembly 410 for conventional venipuncture fordrawing a blood sample from a patient using a needle cannula having aconventional gauge for venipuncture as is known in the art. With such aninternal volume, porous vent 402 is desirably positioned within housinginterior so as to define flashback chamber 426 as having a volume thatrepresents from about 5 percent to about 20 percent of the total overallvolume of housing 412, desirably from about 7 percent to about 12percent of the total overall volume of housing 412, including the volumeof secondary chamber 427 and the volume of the pores within porous vent402. Such a ratio of the flashback chamber 426 to the total overallvolume of the housing 412 assures that flashback chamber 426 hassufficient volume to properly visualize the initial flash, and desirablywhile preventing blood from fully contacting the porous vent 402 atinitial venipuncture, based on the initial build-up of pressure withinsecondary chamber 427 caused by venous pressure forcing the blood intoflashback chamber 426. Such volume ratios are effective for the intendeduse as described in further detail herein, wherein blood flowing intoflashback chamber 426 upon initial venipuncture does not contact porousvent 402, and wherein at least a portion of the air is drawn out fromsecondary chamber 427 based upon application of an evacuated bloodcollection tube to the needle assembly 410. In this manner, secondarychamber 427 can effectively draw blood from within flashback chamber 426and from within fluid inlet cannula 436 toward secondary chamber 427,such as into and through porous vent 402, when patient puncture tip 438is removed from the patient and is exposed to the external environment.In one particular embodiment, the total interior volume of the housing412 is about 380 mm³, with the flashback chamber 426 having a volume ofabout 30 mm³, the secondary chamber 427 having a volume of about 300mm³, and the pores of the porous vent 402 representing a volume of about50 mm³.

Needle assembly 410 may be assembled as follows. Fluid inlet cannula 436is positioned through first end 414 of housing 412 such that the openinterior end 439 is positioned within an interior portion of housing 412at first portion 419 and patient puncture tip 438 extends externally offirst end 414. Fluid outlet cannula 452 is positioned within housing 412through the opposite end, such that open internal end 464 is positionedwithin an interior portion of housing 412 at first portion 419 adjacentinterior end 439 of fluid inlet cannula 436, with a slight gaptherebetween, and with non-patient puncture tip extending externally ofsecond end 416. Fluid inlet cannula 436 and fluid outlet cannula 452 maybe affixed therein in any known manner, desirably through a medicalgrade adhesive.

In alternate embodiments including only a single cannula 470, suchcannula 470 is affixed within housing 412 such that opening 472 ispositioned within the interior of housing 412 at first portion 419, withpatient puncture tip 438 extending externally of first end 414 andnon-patient puncture tip 462 extending externally of second end 416.

Porous vent 402 is then inserted within housing 412 and positioned overfluid outlet cannula 452 (or over the single cannula 470), and element428 is thereafter affixed to the second end 416, enclosing the interiorof housing 412. Sealable sleeve 461 is then affixed over protrusion 429.As such, the interior of housing 412 is closed from the externalenvironment, with the sole path for fluid communication between theinterior of housing 412 and the external environment being providedthrough the patient puncture tip 438.

Needle assembly 410 assembled as such can be used in connection with ablood collection tube holder 403, as depicted in the embodiment shown inFIGS. 15A-15B.

In use, needle assembly 410 may be provided with collection tube holder403 attached thereto. Patient puncture tip 438 is inserted through theskin of a patient and into the patient's vasculature, desirably into avein. Upon venipuncture, a closed environment is achieved within housing412, since housing 412 is an entirely closed structure, and sincesealable sleeve 461 closes off the only outlet of housing 412 (i.e.,fluid outlet cannula 452). The patient's blood pressure causes blood toflow through patient puncture tip 438, into fluid inlet cannula 436, andout interior end 439 (or through opening 472 in the embodiment of FIGS.15A-15B), into flashback chamber 426 surrounding interior end 464 offluid outlet cannula 452. The transparent or translucent nature ofhousing 412 permits visualization of the blood within flashback chamber426, providing an indication that venipuncture is achieved.

Since the interior of housing 412 is a closed environment, the flow ofblood into flashback chamber 426 causes air to be trapped within thehousing interior, including within flashback chamber 426, porous vent402 and secondary chamber 427, as well as within fluid outlet cannula452, causing such trapped air to be slightly pressurized therein.Flashback chamber 426 and secondary chamber 427 are configured throughtheir size and dimensions such that the volumes thereof permit blood toflow into flashback chamber 426 at this initial venipucture, but thebuild up of air pressure within the pores of porous vent 402 and withinsecondary chamber 427 prevents blood from fully contacting porous vent402, and desirably prevents blood from even partially contacting porousvent 402 at the initial venipuncture.

After such initial venipuncture and flash visualization, a samplecollection container having a negative pressure therein, such as anevacuated blood collection tube (not shown) as is commonly known in theart, is inserted within the tube holder 403. The stopper (not shown) ofsuch evacuated container contacts and displaces sealable sleeve 461,causing non-patient puncture tip 462 to puncture through sealable sleeve461 and through the stopper of the evacuated container. At this point,fluid communication is established between the non-patient puncture tip462 and the interior of the evacuated collection container. The negativepressure within the evacuated collection container draws the blood thathas collected within flashback chamber 426 into fluid outlet cannula 452and into the evacuated collection container. Along with the blood withinflashback chamber 426, the negative pressure within the evacuatedcollection container will also draw at least a portion of the air out ofthe flashback chamber 426 and out of the secondary chamber 427 throughthe pores of the porous vent 402, toward and into the evacuatedcollection container. In addition, the close proximity and alignment offluid outlet cannula 452 and fluid inlet cannula 426 causes blood to bedrawn from fluid inlet cannula 436 and from the patient, simultaneouslywith such air being drawn from the flashback chamber 426 and secondarychamber 427.

Such drawing of air reduces the pressure within the flashback chamber426 and the secondary chamber 427, establishing a negative pressuretherein with respect to the patient's blood stream and with respect tothe external environment. This negative pressure that has beenestablished within the interior of housing 412, and specifically withinflashback chamber 426 and secondary chamber 427, draws additional bloodfrom within fluid inlet cannula 436 and from the patient into flashbackchamber 426, with the blood contacting porous vent 402. With such bloodfilling flashback chamber 426, the blood fully contacts the surface ofporous vent 402 that extends within flashback chamber 426, and begins tofill the pores of porous vent 402. Such filling of the pores of porousvent 402 that are directly at the interface of porous vent 402 andflashback chamber 426 closes off the porous vent 402 from airflowtherethrough but does not fully act as a seal, in that the blood doesnot cause the material of the porous vent 402 to swell or close off toair flow, but instead merely physically fills the voids within theporous vent 402. Moreover, since a portion of the air within secondarychamber 427 has been drawn out form secondary chamber 427, the secondarychamber 427 represents a closed chamber with a negative pressure thereinrelative to the external environment. Secondary chamber 427 willtherefore continue to have a drawing effect on the blood within thepores of porous vent 402 and within flashback chamber 426 through thepores of porous vent 402 toward secondary chamber 427, without releasingany air from the secondary chamber 427 in the opposite direction due tothe pores of porous vent 402 at the interface of the flashback chamber426 being filled with blood, thereby effectively preventing air flowthrough porous vent 402 due to the filled pores. The draw created bynegative pressure within secondary chamber 427 has a fluid resistancebased on the blood filling the pores of porous vent 402 and based on thetortuous path created by the pores of the porous vent 402, and thereforeis a gradual draw with reduced fluid movement.

At this point, the evacuated collection container and the secondarychamber 427 are both at a negative pressure with respect to the externalenvironment (and with respect to the patient's bloodstream), andtherefore both effect a draw from the fluid inlet cannula 436. Thiseffect may essentially establish an equilibrium within the flashbackchamber 426, such that the blood contained within the flashback chamber426 is not drawn toward or into either the secondary chamber 427 throughthe pores of porous vent 402 or into the evacuated collection container(through the fluid inlet cannula 436), but instead essentially remainswithin flashback chamber 426 in a steady state. The negative pressure ofthe evacuated collection container draws blood directly from the patientthrough fluid inlet cannula 436, due to the close proximity andalignment of fluid outlet cannula 452 and fluid inlet cannula 436, aswell as due to the equilibrium established within flashback chamber 426(based on the opposite draw forces between the evacuated collectioncontainer and the evacuated secondary chamber 427). The continual drawof blood into the evacuated collection container gradually causes thepressure within the collection container to increase.

Once the evacuated collection container is filled with the desiredamount of blood, the container is removed from the non-patient puncturetip 462, thereby releasing the fluid communication between thenon-patient puncture tip 462 and the evacuated collection container,with sealable sleeve 461 then covering and closing off non-patientpuncture tip 462. Absent such draw from the negative pressure of theevacuated collection tube, the negative pressure within the secondarychamber 427 effects a slight draw on the blood within flashback chamber426 through the pores of porous vent 402. Such draw, however, is veryslow and gradual, due to the tortuous path of blood flow through thepores of porous vent 402.

Additional evacuated collection containers can thereafter be insertedinto tube holder 403 and used for sample collection through non-patientpuncture tip 462 as described above, by placing a second evacuatedcollection container within the holder 403 and establishing fluidcommunication between the non-patient puncture tip 462 and the interiorof the evacuated collection container by puncturing the stopper, asdiscussed. In such further sampling, the evacuated collection containerand the secondary chamber 427 are both at a negative pressure, andtherefore both effect a draw from the fluid inlet cannula 436. As above,this effect essentially establishes an equilibrium within the flashbackchamber 426, thereby preventing the blood contained within the flashbackchamber 426 from being drawn toward or into the secondary chamber 427(through the porous vent 402). The negative pressure of the evacuatedcollection container draws blood directly from the patient through fluidinlet cannula 436 as discussed above, due to the close proximity andalignment of fluid outlet cannula 452 and fluid inlet cannula 426. Onceany such additional evacuated collection containers are filled with thedesired amount of blood, the container is removed from the non-patientpuncture tip 462, thereby releasing the fluid communication between thenon-patient puncture tip 462 and the evacuated collection container,with sealable sleeve 461 then covering and closing off non-patientpuncture tip 462.

Once all of the desired blood samples have been drawn in this manner,patient puncture tip 438 is removed from the vasculature of the patient,thereby exposing the opening of patient puncture tip 438 to the externalenvironment. Since the sole communication path between the housinginterior and the external environment is through patient puncture tip438, the negative pressure established within secondary chamber 427relative to the external environment will affect a gradual draw on theblood contained within flash chamber 426 and within fluid inlet cannula436 toward and through porous vent 402. Such drawing effect will moveany blood contained within fluid inlet cannula 436 away from patientpuncture tip 438, thereby preventing any blood from leaking from patientpuncture tip 438 out of fluid inlet cannula 436. Such negative pressurewithin secondary chamber 427 may continue to have a gradual drawingeffect through the porous vent 402 for a prolonged period of time afterremoval of patient puncture tip 438 from the patient, and may draw allof the remaining blood contained within fluid inlet cannula 436 andflashback chamber 426 through porous vent 402 and/or into secondarychamber 427. Needle assembly 410 can then be properly disposed of in aknown manner. It is anticipated herein, that the flash chamber 426described with reference to FIGS. 11-15B may be employed within any ofthe embodiments described elsewhere in the present application.

In yet another embodiment, FIGS. 16-28 depict an alternativeconfiguration of a needle assembly 230 in accordance with the presentinvention. As shown, needle assembly 230 is similarly constructed to theneedle assembly 30, described above with reference to FIGS. 1-10. Needleassembly 230 includes an alternate release member 208 and an optionalremovable cannula guard 216. Needle assembly 230 generally includes acannula 234 associated with a housing 232, and a safety shield 236adapted for safety shielding the cannula 234 during and/or after use ofthe device. As previously described, the housing 232 may include a hub264, a specimen collection container receiving port 276 and/or aspecimen collection container holder 278, and a second sidewall 286 atleast partially surrounding a sidewall 284 of the specimen collectioncontainer holder 278. The hub 264 may be adapted for at least partiallysupporting the cannula 34, which includes a patient end 240 and anon-patient end 242, as previously described. The cannula 34 may alsoinclude a distal patient needle 252 and a separate proximal non-patientneedle 254, as also previously described. The needle assembly 230further includes a flash chamber 298 defined therein, as previouslydescribed.

As shown in FIGS. 16, 18, 20, and 21-25, the needle assembly 230 isshown in the retracted position with a removable cannula guard 216associated with a portion of the housing 232 and generally shielding thecannula 234. The removable cannula guard 216 is engageable with aportion of the housing 232 and is removable prior to use of the needleassembly 230. The removable cannula guard 216 is provided to shield thecannula 234, in particular, the puncture tip of the patient end 240 ofthe cannula 234, prior to use in a specimen collection procedure. In oneembodiment, the cannula guard 216 is configured to circumferentiallysurround the cannula 234. The cannula guard 216 has a proximal end 246having an interior portion 248 sized to extend at least partially over aportion of the housing 232, such as an exterior surface 253 of the hub264. In another embodiment, the removable cannula guard 216 has aproximal end 246 having an interior portion 248 sized to extend at leastpartially over the exterior surface 253 of the hub 264 and to extendwithin at least a portion of the interior 258 of the distal end 260 ofthe housing 232.

The removable cannula guard 216 may be removably mated to a portion ofthe hub 264 and/or the specimen collection container holder 278, such asby a frictional engagement or press-fit mechanism. Alternately,removable cannula guard 216 may be mated by a threaded engagement (notshown), in which threads (not shown) may be disposed on a portion of thehub 264, or specimen collection container holder 278, and/or removablecannula guard 216. In one embodiment, the proximal end 246 of theremovable cannula guard 216 may have an area of increased thickness 266,as compared to the thickness of the remainder of the removable cannulashield 216, to provide additional support for mating engagement with thehousing 232. In a further embodiment, the area of increased thickness266 if provided is to provide additional support for mating engagementwith the hub 264.

The removable cannula guard 216 may have any suitable dimensions and maybe made of any suitable materials to allow the puncture tip of thepatient end 240 of the cannula 234 to remain shielded prior to useand/or during transport. In one embodiment, the removable cannula guard216 has sufficient strength to allow the needle assembly 230 to bepackaged as a “hardpack” packaging configuration, as is conventionallyknown, without damage to the cannula 234 or needle assembly 230. Anexample removable cannula guard and an example hardpack packagingstructures are disclosed, for example, in U.S. Pat. Nos. 6,997,913 and6,984,223, the entire disclosure of each of which are hereinincorporated by reference.

Prior to use, the removable cannula guard 216 is removed from the needleassembly 230, such as by applying force to disengage the frictionalengagement or press-fit mechanism and/or unscrew the threadedengagement. Once the removable cannula guard 216 has been removed fromthe needle assembly 230, a medical practitioner can use the needleassembly 230 as previously described herein.

Further, as shown specifically in FIGS. 26-28, the needle assembly 230may include an alternative release member 208, such as an alternativepush button. In one embodiment, the release member 208 may actuate thetransition of the safety shield 236 from the retracted position to theextended position. In another embodiment, the release member 208 mayinitiate an activator to transition the safety shield 236 from theretracted position to the extended position. In the embodiment depictedin FIGS. 26-28, the release member 208 includes a member 210 having arestraining portion 212 and a passage region 214, as previouslydescribed. The restraining portion 212 may also define an interiorrecess 218 defined at least in part by two depending arms 220. Theinterior recess 218 is dimensioned to accommodate at least a portion ofthe housing 232, such as a portion of the hub 264, therethrough. FIGS.26-27 are partial perspective views of the needle assembly 230 havingthe shield and cannula removed therefrom to illustrate the mechanism ofthe release member 208. When the release member 208 is in a firstposition, as shown in FIG. 26, the rim 222 may be provided such that itdoes not engage a portion of the hub 264. When the release member 208 istransitioned to the second position, as shown in FIG. 27, both dependingarms 220 are lowered and the rim 222 contacts a portion of the hub 264.

As shown in FIG. 26, when the release member 208 is in a first position,corresponding to the retracted position of the shield (shown in FIG.16), the rim 222 of the interior recess 218 is separated from the hub264 and restraining portions 224 of the depending arms 220 may contactat least a portion of the hub 264. The safety shield is prevented fromtransitioning from the restrained position to the extended position bythe restraining portion 212, as similarly discussed herein in greaterdetail with reference to FIGS. 3-4. As shown in FIG. 27, when therelease member 208 is deployed to the second position, corresponding tothe extended position of the shield (shown in FIG. 17), the rim 222engages at least a portion of the hub 264. The restraining portions 212are advanced beyond the hub 264. Once the restraining portions 212 haveadvanced beyond the hub 264, the hub 264 prevents the release member 208from being returned to its original state prior to activation, such asthrough a locking engagement with hub 264. Also shown in FIG. 17, theneedle assembly 230 may include a plurality of ribs 238 to preventrotation of the safety shield 236 with respect to the housing 232, suchas with respect to the specimen collection container holder 278.

As shown in FIGS. 24-25, the removable cannula guard 216 may furtherinclude a portion in abutment with a portion of release member 208,thereby physically preventing deployment of the release member 208 untilthe removable cannula guard 216 is removed from the needle assembly 230.In one embodiment, the removable cannula guard 216 includes a tab 274that extends at least partially within the interior recess 218 (shown inFIG. 28) of the release member 208, thereby preventing transition of therelease member 208 from a first position, as shown in FIG. 16, to asecond position, as shown in FIG. 17. Accordingly, accidental transitionof the safety shield 236 from a retracted position to the extendedposition is prevented during transport or standard pre-use handling.

Moreover, as shown in FIGS. 22-23, a tamper-resistant flange 278 may beprovided adjacent the distal end 260 of the housing 232, such asadjacent the distal end 282 of the second sidewall 286 to prevent theforced re-entry of the safety shield 236 into the housing 232 once thesafety shield 236 has been transitioned from the retracted position tothe extended position. In one embodiment, the flange 278 is attached to,or integral with, an exterior surface 284 of the second sidewall 286 atthe distal end 282 and oriented to extend beyond the distal end 282 ofthe housing 232 in the distal direction. As shown in FIG. 23, when theneedle assembly 230 is in the extended position, the flange 278 mayshield a barrier mechanism 292, similar to the barrier mechanismpreviously described herein with reference to FIGS. 9-10. The barriermechanism 292 is structured to prevent the re-entry of the safety shield236 into the housing 232 once the safety shield 236 has beentransitioned from the retracted position to the extended position.However, in certain configurations, it may be possible to insert a prytool (not shown) between the safety shield 236 and a portion of thehousing 232 thereby flexing the needle assembly 230 to a sufficientdegree that abutting portions of the barrier mechanism 292 can becomedisengaged, thereby allowing re-entry of the safety shield 236 into thehousing 232. In order to prevent insertion of such a pry tool, flange278 may be provided to shield the distal end 260 of the housing 232 fromtampering.

FIGS. 29-38 depict another embodiment of the present invention, in whicha needle assembly 330 is similarly constructed as described above, withthe exception of the configuration of the housing 332. Needle assembly330 generally includes a cannula 334 associated with the housing 332,and a safety shield 336 adapted for safety shielding of the cannula 334during and/or after use of the device. Needle assembly 330 furtherincludes a hub 364 for supporting at least a portion of the cannula 334and a flash chamber 398 as previously described.

In the embodiment shown in FIGS. 29-38, the housing 332 may include afirst portion 344, with a second portion 346 connected to the firstportion 344. The first portion 344 may be distal to the second portion346 along the transition axis T (shown in FIG. 32) of the shield 336. Inone embodiment, the first portion 344 and the second portion 346 areco-formed. In another embodiment, the first portion 344 and the secondportion 346 are separately formed and subsequently assembled. In yetanother embodiment, the first portion 344 and the secondary portion 346may be secured together in a bayonet fashion. Alternatively, the firstportion 344 and the secondary portion 346 may be adhered togetherthrough the use of conventional adhesives.

As shown in FIGS. 33-34, the cannula 334 may be positioned in partwithin the interior 350 of the secondary portion 346 and in part withinthe interior 352 of the first portion 344. In another embodiment, thenon-patient end 342 of the cannula 334 may be positioned within theinterior 350 of the secondary portion 346, and at least the puncture tipof the patient end 340 of the cannula 334 extending beyond the firstportion 344. The hub 364 may be positioned within the interior 352 ofthe first portion 344, although in certain embodiments it may bedesirable to position the hub 364 in part within the interior 350 of thesecondary portion 346 and in part within the interior 352 of the firstportion 344. In another embodiment, the secondary portion 346 mayinclude a conventional specimen collection container holder 378. In yetanother embodiment, a specimen collection container receiving port 380,engageable with a specimen collection container (shown in FIG. 123), isdefined within the secondary portion 346.

The flash chamber 398 is visible to a medical practitioner when thesafety shield 336 is in the retracted position, as shown in FIG. 29.Referring again to FIGS. 29-34, the housing 332, such as the firstportion 344, may include a sidewall 358 having an observation window360, shown in FIGS. 29-32, defined therein. In one embodiment, theobservation window 360 includes an opening surrounded entirely by asidewall 358. In another embodiment, the observation window 360 includesa cut-away portion of the housing 332. In another embodiment, theobservation window 360 includes a translucent and/or transparentmaterial within the opening. In yet another embodiment, the observationwindow 360 includes a cut-away portion that is at least partially open,i.e., the observation window 360 is not entirely surrounded by asidewall 358 of the housing 332.

In accordance with an embodiment of the present invention, at least aportion of the flash chamber 398 is visible through the observationwindow 360 when the shield 336 is in the retracted position. In anotherembodiment, at least a portion of the first portion 344 of the housing332 defines an observation window 360 and the flash chamber 398 isvisible through the observation window 360 of the first portion 344 ofthe housing 332 when the shield is in the retracted position. In anotherembodiment, the safety shield 336 may be formed of a translucent and/ortransparent material such that the flash chamber 398 is visible throughboth the observation window 360 and a portion of the safety shield 336.In another embodiment, both the safety shield 336 and the first portion344 of the housing 332 are made of a transparent material or translucentmaterial, such that the flash chamber 398 is visible through bothstructures. The first portion 344 and the safety shield 336 can be madeof the same or different translucent and/or transparent materials. Inanother embodiment, the patient end 340 of the cannula 334 may include abevel 338 and the position of the observation window 360 within thehousing 332 corresponds to the orientation of the bevel 338, i.e., theorientation of the angled surface of the bevel 338. This may assistmedical practitioners in properly orienting the cannula 334 within thepatient without visually observing the patient end 340 of the cannula334.

As shown in FIG. 33, the safety shield 336 may be disposed entirelywithin the first portion 344 of the housing 332 in the retractedposition. In one embodiment, the safety shield 336 is adapted to atleast partially surround, such as circumferentially surround, at least aportion of the cannula 334. In one embodiment, the safety shield 336 maybe made of a substantially rigid material. In another embodiment, thesafety shield 336 may be made of any substantially resilient deformablematerial having an elasticity sufficient that the safety shield 336 maybe compressed and expanded without substantial damage thereof, such thatit may be configured to fold against itself in an accordion foldingarrangement.

As shown in FIGS. 33-34, a spring 368 may be biased between a portion ofthe safety shield 336 and a portion of first portion 344 of the housing332. In one embodiment, the spring 368 is biased between a proximalportion 372 of the shield 336 and an inner surface 384 of the interior352 of the first portion 344. In another embodiment, the spring 368 isbiased between a proximal portion 372 of the shield 336 and a distal end376 of the secondary portion 346. In yet another embodiment, the spring368 is biased between a biasing portion 388 of the safety shield 336 andeither of an inner surface 384 of the interior 352 of the first portion344 and a distal end 376 of the secondary portion 346.

As shown in FIGS. 29-38, the safety shield 336 may be transitioned fromthe retracted position, shown in FIG. 29, to the extended position,shown in FIG. 30, by spring 368. During transition of the safety shield336 from the retracted position to the extended position, spring 368advances the safety shield 336 from a position within the first portion344 of the housing 332 to a location distal from the distal portion 392of the first portion 344. In this embodiment, the safety shield 336 isadapted to move between the retracted position, in which at least thepuncture tip of the patient end 340 of the cannula 334 is exposed foraccessing the patient, and the extended position in which the puncturetip of the patient end 340 is encompassed or otherwise safely shieldedfrom exposure. The safety shield 336 may be at least partially deployedover the cannula 334 while the cannula 334 is accessing the interior ofthe patient's blood vessel (not shown), or after the cannula 334 hasbeen removed from the patient. If the transition of the safety shield336 from the retracted position to the extended position occurs whilethe cannula 334 is accessing the interior of a patient's blood vessel,the distal portion 394 of the safety shield 336 will contact thepatient's skin.

In yet another embodiment, the needle assembly 330 may further include abarrier mechanism 396, similar to the barrier mechanisms previouslydescribed, to prevent the safety shield 336 from re-entering the housing332 once the safety shield 336 has been transitioned from the retractedposition to the extended position. Alternatively, as shown in FIGS.33-34, the restraint 390 and break 386 are shown in oppositearrangement, such that the break 386 is incorporated within the housing332, specifically the distal end 392 of the first portion 344, and therestraint 390 is incorporated within the safety shield 336 adjacent aproximal portion 372 of the shield 336.

As shown in FIGS. 29-36, a release member 308, such as a push button,may actuate the transition of the safety shield 336 from the retractedposition to the extended position. In another embodiment, the releasemember 308 may initiate an activator to transition the safety shield 336from the retracted position to the extended position. In the embodimentdepicted in FIGS. 29-34, the release member 308 may operate in asubstantially similar fashion to the release members previouslydescribed, however, the passage region 310 may define at least onesubstantially circular opening. As shown in FIG. 36, the restrainingportion 312 of the release member 308 may also define a partiallycircular opening. FIG. 35 shows a cut away view of the needle assembly330 with the release member 308 in the first position, corresponding tothe shield 336 in the retracted position. As shown in FIG. 35, therestraining portion 312 is engaged with at least a portion of the safetyshield 336, such that a shoulder 314 of the release member 308 preventsthe safety shield 336 from transitioning to the extended position by thebias of the spring 368. In this configuration, the restraining portion312 and the passage region 310 define continuous partially circularopenings having different diameters. In one embodiment, the passageregion 310 has a diameter D₁ and the restraining portion 312 has adiameter D₂, wherein D₂is smaller than D₁. When the release member 308is in the first position, the safety shield 336 is at least partiallyaligned with and restrained by the diameter of the opening of therestraining portion 312, thereby holding the safety shield 336 in theretracted position. When the release member 308 is transitioned to thesecond position, the restraining portion 312 is advanced below thesafety shield 336 and the passage region 310, having an opening ofincreased diameter is aligned with the safety shield 336, therebyallowing the safety shield 336 to transition therethrough.

In one embodiment, the restraining portion 312 may be sized tocircumferentially surround a portion of the housing 332, such as the hub364. Optionally, the release member 308 may include a stabilizingfeature for stabilizing the release member 308 in the first position andengaging a corresponding shoulder 318 of the housing 332, such as shownin FIGS. 29 and 35. In one embodiment, the stabilizing feature mayinclude a detent protrusion 316, such as two detent protrusions 316, forengaging a corresponding shoulder 318 of the housing 332 and stabilizingthe release member 308 in the first position. When the release member308 is depressed in the direction shown by arrow R in FIGS. 29 and 36,the safety shield 336 is transitioned to the extended position, shown inFIG. 30. As the release member 308 is advanced in the direction shown byarrow R, the detent protrusions 316 are advanced in a downward directionand are received within a recess 320, shown in FIG. 35, within thehousing 332. Due to the increased diameter of the passage region 310, ascompared to the diameter of the restraining portion 312, and thepresence of the detent protrusion 316 within the recess 320, the safetyshield 336 is advanced through the passage region 310, therebytransitioning the safety shield 336 from the retracted position to theextended position.

Further, as shown in FIGS. 37-38, the needle assembly 330 may include aremovable cannula guard 324 for surrounding the cannula 334,particularly the puncture tip of the patient end 340, prior to use. Aspreviously described herein, the removable cannula guard 324 may includea tab portion 326 structured to prevent transition of the release member308 from a first position to a second position. In this embodiment, thetab portion 326 includes an upper surface 354 structured to face a lowersurface 356 of the release member 308 to provide an abutment orinterference therebetween. Once a medical practitioner removes theremovable cannula guard 324 from the needle assembly 330, the releasemember 308 may be deployed as described herein.

As shown in FIGS. 37-38, the removable cannula guard 324 may include atapered portion 328 having a contour for allowing a medical practitionerto more easily grip the removable cannula guard 324 for removal from theneedle assembly 330. In another embodiment, the removable cannula guard324 may have a reinforcing tube 348 disposed within the interior of theremovable cannula guard 324 and structured to at least partiallysurround the cannula 334. The reinforcing tube 348 may also includefastening means 362 for removeably securing the removable cannula guard324 to the hub 364 of the needle assembly 330. In one embodiment, thefastening means 362 can include corresponding friction-fit or press-fitstructures. In another embodiment, the fastening means 362 can includecorresponding threaded structures for mating engagement allowing amedical practitioner to remove the removable cannula guard 324 from theneedle assembly 330 by rotational movement of the removable cannulaguard 324 with respect to the housing 332.

FIGS. 39-58 illustrate yet another embodiment of a needle assembly 530of the present invention. FIGS. 39, 41, 43, 45, and 47 each illustratethe needle assembly 530 with a removable cannula guard 512 which must beremoved prior to use of the needle assembly 530, as previouslydescribed. The removable cannula guard 512 may include a tab portion 512a structured to prevent depression of the release member 508. In thisembodiment, the tab portion 512 a is designed to provide an abutment orinterference between the release member 508 and the safety shield 536,as previously described.

The needle assembly 530 generally includes a cannula 534 associated witha portion of the housing 532, such as a hub 564 for supporting at leasta portion of the cannula 534, and/or a specimen collection containerholder 578. The needle assembly also generally includes a safety shield536 adapted for safety shielding the cannula 534 during and/or after useof the needle assembly 530. The needle assembly 530 further includes aflash chamber 598 within at least a part of the housing 532, aspreviously described.

In one embodiment, the needle assembly 530 includes a first portion 538,with a secondary portion 540 connected to the first portion 538. Thesecondary portion 540 defines an interior 542 structured to receive thespecimen collection container, such as an evacuated blood collectiontube (not shown) therein. In one embodiment, the secondary portion 540is a specimen collection container holder 578. In another embodiment,the secondary portion 540 is a blood collection container holder 578 andthe needle assembly 530 is a blood collection assembly 530.

In one embodiment, the secondary portion 540 includes an arcuateproximal end 544. As shown specifically in FIGS. 41-42, the sideportions of the arcuate proximal end 544 each define a generally concaveproximal region 546 and, as shown specifically in FIGS. 43-44, the topand bottom portions of the arcuate proximal end 544 each define agenerally convex proximal region 548 separated by the generally concaveproximal regions 546 of the side portions. Optionally, the exteriorsurface 550 of the secondary portion 540 may include opposing ridgedareas 552 for allowing a medical practitioner to easily grasp thesecondary portion 540. In one embodiment, the opposing ridged areas 552may be made of a tacky elastomeric material.

The distal end 554 of the secondary portion 540 may also include anengagement mechanism 556 for engaging the first portion 538. In oneembodiment, the distal end 554 of the secondary portion 540 includes atleast one recess 558, shown in FIGS. 47-48, for mating engagement with aprotrusion 560 integral with the proximal end 562 of the first portion538. The first portion 538 and the secondary portion 540 may be securedtogether by a press-fit locking mechanism, a threaded screw mechanism, abayonet mechanism, or may be adhered together through the use ofconventional adhesives. Optionally, the exterior surface 566 of thefirst portion 538 may also include opposing ridged areas 568 forallowing a medical practitioner to easily grasp the first portion 538.The cannula 534 may be positioned in part within the interior 42 of thesecondary portion 540 and in part within the interior 570 of the firstportion 538, as previously described.

Optionally, the secondary portion 540 of the present embodiment caninclude at least one tube preload indicator 572 for indicating to amedical practitioner the appropriate depth to which a specimencollection container, such as an evacuated blood tube, can be insertedwithout accessing the interior of the evacuated blood tube, such as bypenetration of the cannula 534. Optionally, a portion of the cannula 534may be protected by a pierceable sleeve 582 disposed about the proximalend of the cannula 534. In one embodiment, the preload indicator 572 maybe a raised or recessed band disposed within the interior or exteriorsurface of the secondary portion 540, such as within an interior orexterior surface of the sidewall of the secondary portion 540.Alternatively, the preload indicator 572 can be a colored or texturedband within the interior or exterior of the secondary portion 540. Inanother embodiment, the preload indicator 572 can be a continuous orsegmented band. In this manner, an evacuated blood collection tube canbe “pre-loaded” into the needle assembly 530 prior to use.

In one embodiment, the hub 564 at least partially supports the cannula534, as previously described. The hub 564, including rear hub portion574 and forward hub portion 576, is desirably molded from a transparentor translucent polymeric material or resin. As such, the hub 564, and inparticular forward hub portion 576, defines a flash chamber 598. In oneembodiment, the rear hub portion 574 engages the forward hub portion 576through a portion of the secondary portion 540 of the housing 532 toform a sealed flash chamber 598. In this configuration, the flashchamber 598 can be formed by introduction of the rear hub portion 574through the interior 542 of the secondary portion 540 for engagementwith a portion of the forward hub portion 576 disposed within theinterior 570 of the first portion 538. The housing 532 may include aforward hub portion 576 and a rear hub portion 574 connectable with theforward hub portion 576 and defining the flash chamber therebetween. Inone embodiment, a protrusion 580 of the rear hub portion 574 extendsthrough the secondary portion 540 of the housing 532 and matinglyengages a corresponding recess within the forward hub portion 576.Accordingly, in one configuration, the rear hub portion 574 isconnectable with the forward hub portion 576 through at least a portionof a specimen collection container holder 578, shown in FIG. 39. Inanother configuration, the rear hub portion 576 defines a specimencollection container receiving port 504 therein, shown in FIG. 55.

As shown in FIG. 49, in one embodiment at least a portion of the rearhub portion 574 is restrained within the interior 542 of the secondaryportion 540, such that a portion of the flash chamber 598 may be formedwithin the secondary portion 540, such as within a blood collection tubeholder. In another embodiment, the flash chamber 598 can be formed atleast partially within the forward hub portion 576 and at leastpartially within rear hub portion 574. In this configuration, a slimprofile of the needle assembly 530 can be maintained while increasingthe volume of the interior of the flash chamber 598 visible to a medicalpractitioner when the safety shield 536 is in the retracted position.

As shown in FIG. 49, in one embodiment, the void 598 a formed betweenthe forward hub portion 538 and the rear hub portion 540 may allow forthe compression of air therein, thereby creating sufficient pressure toforce fluid, such as blood, entering the cannula 534 to be forced intothe flash chamber 598. In one embodiment, the void 598 a is sized toaccommodate a sufficient volume of compressed air to force bloodentering the cannula 534 into the flash chamber 598.

Transition of the safety shield from the retracted position, shown inFIG. 39 with the removable cannula guard 512 in place, to the extendedposition, shown in FIG. 40, may be effected as previously described. Inone embodiment, a spring 584 disposed between a portion of the safetyshield 536 and a portion of the housing 532 biases the safety shield 536toward the extended position. In another embodiment, a release member508, such as a push button, may actuate the transition of the safetyshield 536 from the retracted position to the extended position, aspreviously described. Alternatively, the release member 508 may initiatean activator to transition the safety shield 536 from the retractedposition to the extended position, also as previously described.

During transition of the safety shield 536 from the retracted positionto the extended position, the spring 584 advances the safety shield 536from a position at least partially within the first portion 538 of thehousing 532 to a location distal from the distal region 586 of the firstportion 538, as shown in FIGS. 43-44. In this embodiment, the safetyshield 536 is adapted to move between the retracted position, in whichat least the puncture tip of the patient end 588 of the cannula 534 isexposed for accessing the patient, and the extended position in whichthe puncture tip of the patient end 588 of the cannula 534 isencompassed or otherwise safely shielded from exposure. It is noted thatalthough FIGS. 39, 41, 43, 45, and 47 each show the removable cannulaguard 512 disposed over the cannula 534 in the retracted position, theremovable cannula guard 512 is removed prior to use of the needleassembly 530, in which the cannula 534 is exposed.

As shown in FIG. 44, in the extended position, the safety shield 536 isretained within the distal region 586 of the first portion 538 by theengagement of proximal rim 590 of the safety shield 536 against distalrestraint 592 of the first portion 538. As shown in FIG. 48, also in theextended position, the safety shield 536 is prevented from re-enteringthe first portion 538 of the housing 532, beyond the engagement at thedistal region 586, by the engagement of the proximal rim 590 of thesafety shield 536 and the barrier mechanism 594 of the first portion 538of the housing 532.

As shown in FIG. 48, the barrier mechanism 594 may include a locking tab596 that is deflectable upon transition of the safety shield 536 fromthe retracted to the extended position, but substantially resistsdeflection once the safety shield 536 is in the extended position. Thelocking tab 596 may include a tapered surface 528 which allows thesafety shield 536 to advance thereover due to the applied force ofspring 584 during transition from the retracted position to the extendedposition. The locking tab 596 may also include a stopped surface 526 toprevent the safety shield 536 from passing over the locking tab 596 oncetransition from the retracted position to the extended position hasoccurred. Therefore, the safety shield 536 of the needle assembly 530remains locked in place over the cannula 534 once the safety shield 536has been transitioned from the retracted position to the extendedposition.

As shown in FIGS. 51-52, an alternative locking tab 596 a may beincluded within the needle assembly 530. The locking tab 596 a includesa similar geometry as described above, permitting transition of thesafety shield 536 thereover by deflection when the shield 536 istransitioned from the retracted position to the extended position, andsubstantially resisting axial deflection once the shield 536 has beentransitioned to the extended position. As shown in FIG. 52, a portion ofthe housing 532 may be disposed about the locking tab 596 a tosubstantially resist deflection in the radial direction as shown by thearrow B in FIG. 52.

As shown in FIGS. 53-55, during assembly of the present embodiment, thecannula 534 may be joined with the forward hub portion 576 and the rearhub portion 574 to form hub 564 having a flash chamber 598 therein, withthe cannula 534 in fluid communication with the interior of the flashchamber 598. A spring 584 may be disposed between the forward hubportion 576 and a portion of the safety shield 536. The safety shield536 may be inserted within an interior of a second housing portion 532 athrough a portion of the release member 508. As shown in FIG. 53, aportion of the housing 536 may include a joining mechanism 522 forengaging a corresponding tab 524 on the hub 564 to engage the hub 564with a second housing portion 532 a. As shown, locking tabs 596 a may beprovided within a distal end of the second housing portion 532 a. Whenthe hub 564 and the second housing portion 532 a are joined, the shield536 is biased toward the extended position by the spring 584. However,the release element 508 restrains the bias of the spring in the firstposition by engaging a shoulder 514 of the safety shield 536 and therestraining portion 520 of the release member 508. As shown in FIGS.53-55, assembly of the release member 508 may be accomplished for aproximal or rearward direction, however, it is also contemplated hereinthat assembly may be directed from an upwardly direction, as shown inFIGS. 65-66, or from a distally or frontward direction.

As shown in FIG. 56, the hub 564 may be formed by engaging the forwardhub portion 576 with the rear hub portion 574. The cannula 534 may beengaged with and partially supported by at least one of the forward hubportion 576 and the rear hub portion 574. A porous plug 510 may bedisposed between the forward hub portion 576 and the rear hub portion574 within the flash chamber 598 defined therebetween and in fluidcommunication with the cannula 534.

As shown in FIGS. 57-58, a needle assembly 530 may include a non-patientneedle 516 (or the non-patient end of the cannula) having a pierceablesleeve 582 disposed thereover and may be aligned with the patient needle518 through the flash chamber 598 defined within the hub 564. A spring584 may be disposed between the forward hub portion 576 and a portion ofthe safety shield 536. The safety shield 536 may be inserted within aninterior of a second housing portion 532 a through a portion of therelease member 508. The combined safety shield 536, second housingportion 532 a, hub 564, and cannula 534 may be inserted within a thirdhousing portion 532 b, such as a specimen collection container holder ora blood collection tube holder.

It is anticipated herein that the hub 564, cannula 534, safety shield536, and second housing portion 532 a may be integrally provided withina third housing portion 532 b, such as a blood collection tube holder.Alternatively, hub 564, cannula 534, safety shield 536, and secondhousing portion 532 a may be provided as a non-integral arrangement inwhich the hub 564 may include a specimen collection container receivingport 504, shown in FIG. 55, adapted for later engagement with a specimencollection container.

As shown in FIGS. 59-63, the non-integrated needle assembly 630 issimilarly structured to the embodiments described above. In oneembodiment, the forward hub portion 674 and the rear hub portion 676 arejoined, such as permanently joined, via a weld adjacent the outercircumference 678 of the hub 664. The flash chamber 698 may be formedbetween the forward hub portion 674 and the rear hub portion 676. Inanother embodiment, at least one of the forward hub portion 674 and therear hub portion 676 are formed, such as molded, from a transparent ortranslucent polymeric material or resin. Accordingly, the flash chamber698 may be visible to a medical practitioner through the hub 664.

A first housing portion 632 a may be disposed about at least a portionof the forward hub portion 674 and the safety shield 636 and removablecannula guard 612 may be disposed about the patient end 640 of thecannula 634 and engaged with the first housing portion 632 a, aspreviously described. A distal cannula guard 646 may be provided for atleast partially surrounding the non-patient end 642 of the cannula 634,prior to use. The distal cannula guard 646 may engage at least a portionof the first housing portion 632 a and can be removed therefrom uponapplication of typical manual pressure. Both the distal cannula guard646 and the removable cannula guard 612 are provided to shield thenon-patient end 642 of the cannula 634 (or non-patient needle) and thepatient end 640 of the cannula 634 (or patient needle) from accidentalcontact with medical practitioners prior to initiation of a medicalprocedure.

The rear hub portion 676 further includes a specimen collectioncontainer engagement port 656, shown in FIGS. 61 and 63, which isengageable with a specimen collection container holder 652 (as shown inFIG. 64), such as a blood collection tube holder. In another embodiment,the specimen collection container engagement port 656 is directlyengageable with a specimen collection container, such as an evacuatedblood collection tube. It is further contemplated herein, that a flashchamber similar to the configuration shown in FIG. 49 with reference to598, may be employed within the present design.

As shown in FIGS. 65-66, an additional mechanism 668 of the needleassembly 630 is shown. In this embodiment, the release member 608 isadapted to transition from a first position to a second position, aspreviously described. Release member 608 further includes a projection610 which deforms at least a portion of the housing 632, such as tabportion 638 adjacent the release member 608, when the release member istransitioned from the first position to the second position. Deformationof the tab portion 638 of the housing 632 restrains the release member608 in the second position, thereby preventing the release member 608from returning to the first position.

FIGS. 67-72 depict another embodiment of the present invention, in whichcollection assembly 730, is similarly constructed to the above-describedembodiments, with the exception of the configuration of safety shield736 and the attachment of safety shield 736 to the housing 732. Needleassembly 730 generally includes a cannula 734, associated with thehousing 732, such as supported by a hub 764, as previously described. Aflash chamber 798 is associated with a portion of the housing 732, suchas defined within the hub 764.

In the embodiment shown in FIGS. 67-72, the safety shield 736 mayinclude a first portion 710, such as an arm portion, and a secondportion 712, such as a shield portion, with the second portion 712connected to the first portion 710. The first portion 710 is configuredto slideably engage a portion of the housing 732 along the longitudinalaxis L, shown in FIG. 71, of the cannula 734 when a medical practitionerapplies typical manual force to the safety shield 736 substantially inthe direction shown by arrow C. In one embodiment, the first portion 710is configured to slideably engage, such as glide along, a glidemechanism 714 integral with the housing 732. In another embodiment, aportion of the housing 732 and a portion of the safety shield 736 definean engaging glide mechanism 714, wherein a portion of the safety shield736 is axially transitionable with respect to a portion of the housing732.

In one embodiment, the first portion 710 includes a protrusion 718 forslideably engaging a groove 720 recessed into a portion of the exteriorsurface 716 of the housing 732, thereby establishing a glide mechanism714. In another embodiment, the first portion 710 includes a recess forslideably engaging a protrusion extending above the exterior surface 716of the housing 732. The first portion 710 may include a grip region 722for receiving the finger of a medical practitioner to aid in theadvancement of the safety shield 736 from the retracted position, shownin FIG. 67, to the extended position, shown in FIG. 68 along the glidemechanism 714.

The second portion 712 of the safety shield 736 is adapted to at leastpartially surround, such as circumferentially surround, a portion of thehub 764 disposed at least partially within the housing 732 when theshield 736 is in the retracted position, such that the flash chamber 798defined therein, is at least partially visible to a medical practitionerwhen the safety shield 736 is in the retracted position. In oneembodiment, at least a portion of the flash chamber 798 is visible to amedical practitioner through an observation window 724 or cutawayportion within the second portion 712 of the safety shield 736. Inanother embodiment, the second portion 712 of the safety shield 736 maybe constructed of a transparent material and/or translucent material,such that the flash chamber 798 may be visible therethrough.

In this embodiment, the safety shield 736 is adapted to move between aretracted position, as shown in FIG. 67, in which at least the puncturetip of the patient end 740 of the cannula 734 is exposed for accessingthe patient, and an extended position, shown in FIG. 68, in which thepuncture tip of the cannula 734 is encompassed or otherwise safelyshielded from exposure. The second portion 712 of the safety shield 736is adapted to at least partially surround, such as circumferentiallysurround, at least a portion of the cannula 734 in the extendedposition. In another embodiment, the patient end 740 of the cannula 734is at least partially surrounded by the second portion 712 of the safetyshield in the extended position.

The safety shield 736 may be deployed over the cannula 734 while thecannula 734 is accessing the interior of the patient's blood vessel (notshown), or after the cannula 734 has been removed from the patient. Ifthe transition of the safety shield 736 from the retracted position tothe extended position occurs while the cannula 734 is accessing theinterior of a patient's blood vessel, the distal portion 744 of thesafety shield 736, such as of the second portion 712 of the safetyshield 736, will contact the patient's skin. In one embodiment, thesafety shield 736 includes a detent mechanism to temporarily restrainthe safety shield 736 in a retracted position and a locking mechanism750 adapted to maintain the safety shield 736 in the extended positionafter it is moved thereto. As shown in FIG. 71, the first portion 710 ofthe safety shield 736 may include a locking mechanism 750 which isdeflected or otherwise radially biased against a portion of the housing732, such as by a portion of the first portion 710, when the safetyshield 736 is in the retracted position. As shown in FIG. 72, once thesafety shield 736 is transitioned to the extended position, the lockingmechanism 750 is advanced, such as longitudinally advanced along thelongitudinal axis L of the cannula 734 until contact with the housing732 is disrupted. At this point, the radially biasing forces maintainingthe locking mechanism 750 in a substantially parallel orientation withrespect to the cannula 734 are released, and the locking mechanismswings toward the cannula 734, as shown by arrow D, to engage a distalend of the housing 732. Once the locking mechanism 750 is engaged withthe distal end of the housing 732, retraction of the safety shield 736from the extended position to the retracted position is prevented.

An alternative needle assembly 830 having a glideable safety shield 836is shown and described with reference to FIGS. 73-86. In thisconfiguration, the needle assembly 830 generally includes a cannula 834associated with a portion of the housing 832, and a safety shield 836adapted for safety shielding of the cannula 834 during and/or after useof the device. A proximal portion 838 of the interior of housing 832 maybe configured to receive an evacuated blood collection tube (not shown)therein and may include an interior ridge 840, as shown in FIG. 76, forlimiting the advancement of the evacuated blood collection tube throughthe proximal portion 838 of the housing 832.

The cannula 834, may include a distal patient needle 44 (or a patientend of a single cannula) and a proximal non-patient needle 46 (or anon-patient end of a single cannula). The proximal non-patient needle 46may be provided for puncturing of an evacuated blood collection tube(not shown). Distal patient needle 44 may be beveled to define apuncture tip for puncturing the skin of a patient and accessing thepatient's vasculature. The cannula 834 is supported by at least aportion of the housing 832, such as a hub portion 864. A flash chamber898 may be defined within the hub 864 as previously described. In oneembodiment, the hub 864 and the cannula 834 can be integrally formedwith the remainder of the housing 832. Alternatively, the hub 864 and/orthe cannula 834 can be separately formed and subsequently assembled.

In the embodiment shown in FIGS. 73-86, the safety shield 836 mayinclude a first portion 810, such as an arm portion, and a secondportion 812, such as a shield portion. The first portion 810 and thesecond portion 812 are connected. The first portion 810 may include agrip portion 814 for receiving the finger of a medical practitioner toaid in the advancement of the safety shield 836 from the retractedposition in which the patient end 44 is exposed, shown in FIGS. 75-79,to the extended position in which the patient end 44 is shielded, shownin FIGS. 82-86.

The safety shield 836 is configured to slideably engage a portion of thehub 864 along a glide mechanism 816 established by the interface of anupper surface 820 of the hub 864 and a lower surface 818 of the safetyshield 836, such as a lower surface of the second portion 812 of thesafety shield 836. The interface of the upper surface 820 and the lowersurface 818 may be provided as a frictional slide between the twosurfaces. Alternatively, the upper surface 820 may be provided with aprotrusion (not shown), as previously described, for receipt within acorresponding groove (not shown), as previously discussed, within aportion of the lower surface 818. Alternatively, the upper surface 820may be provided with a groove (not shown) for receipt of a protrusion(not shown) extending from a portion of the lower surface 818.

In one embodiment, the first portion 810 of the shield 836 may slideablyengage a portion of the hub 864 along the longitudinal axis T (shown inFIG. 75) of the cannula 834. As shown in FIG. 77, the first portion 810of the shield 836 may have a first end 850 which slideably engages aportion of the hub 864, such that the lower surface 818 of the shield836 slideably engages the upper surface 820 of the hub 864. The firstportion 810 of the shield 836 may also have a second end 852, shown inFIGS. 77-78, extending at least partially through a portion of thehousing 832. In another embodiment, the second end 852 of the firstportion 810 may extend at least partially through a portion of the outersurface 856 of the housing 832. In yet another embodiment, as shown inFIG. 75, the second end 852 of the first portion 810 extends at leastpartially through a groove 858 defined in the outer surface 856 of thehousing 832. The groove 858 may extend within the housing 832substantially along the longitudinal axis T of the cannula 834. Thefirst portion 810 of the shield 836 may slide within the groove 858 asthe shield 836 is transitioned from the retracted position to theextended position. In another embodiment, as shown in FIG. 74, the firstportion 810 may have a contoured surface 868 that substantiallycorresponds to a distal contoured surface 870 of the housing 832.

The second portion 812 of the safety shield 836 is adapted to at leastpartially surround, such as circumferentially surround, at least aportion of the hub 864 in the retracted position. In one embodiment, thesecond portion 812 is disposed about a portion of the cannula 834 andaxially aligned with a portion of the first portion 810 to transitionabout the cannula 834 from the retracted position to the extendedposition.

The safety shield 836 may also be prevented from unintentionaladvancement from the housing 832, prior to initiation by a medicalpractitioner, by the resistance engagement of a portion of the shield836 with a portion of the housing 832 and/or hub 864. Upon applicationof force by a medical practitioner to the grip portion 814 in thedirection shown by arrow R in FIG. 78, the safety shield 836 is advancedin a distal direction along the longitudinal axis T, shown in FIG. 75,from the housing 832.

With reference to FIGS. 79 and 86, the safety shield 836 may includerestraining means 874 for preventing transition of the shield 836 fromthe extended position to the retracted position, once the shield 836 hasbeen transitioned from the retracted position to the extended position.During transition of the safety shield 836 from the retracted positionto the extended position, a proximal protrusion 876 of the safety shield836 is advanced through a restraint notch 878 within the housing 832and/or hub 864, such as within the glide mechanism 816.

The restraint notch 878 may include a triangular portion 880 structuredto allow the proximal protrusion 876 of the safety shield 836 to easilypass therethough, and a restraining surface 882 structured to preventre-entry of the proximal protrusion 876 of the safety shield 836 oncethe transition of the safety shield 836 from the retracted position tothe extended position has occurred. In this manner, once the safetyshield 836 has shielded the patient end 844 of the cannula 834, thesafety shield 836 may not re-enter the housing 832.

In one embodiment, the flash chamber 898 is at least partially visibleto a medical practitioner when the safety shield 836 is in the retractedposition. Accordingly, a portion of the shield 836, such as the secondportion 812, may be constructed of a transparent material and/ortranslucent material, such that the flash chamber 898 may be visibletherethrough.

FIGS. 87-91 depict another embodiment of the present invention, in whichcollection assembly 930 is constructed as similarly described above,with the exception of the configuration of safety shield 936 and theattachment of safety shield 936 to the housing 932. Needle assembly 930generally includes cannula 934 associated with the housing 932, and asafety shield 936 adapted for safety shielding of the cannula 934 duringand/or after use of the device. Needle assembly 930 further includes ahub 964 for supporting the cannula 934 and defining a flash chamber 998,as previously described, therein.

In the embodiment shown in FIGS. 87-91, a safety shield 936 includes adepending arm 940 attached to the exterior surface 942 of the housing932. The depending arm 940 may include a plurality of extendablesegments 948, such as first extendable segment 944 connected to secondextendable segment 950. In one embodiment, the first extendable segment940 may be pivotally or hingedly connected, such as by a pivot 956, tothe base portion 952 of the depending arm 940, allowing the firstextendable segment 944 to articulate with respect to the base portion952. In another embodiment, the second extendable segment 950 may bepivotally or hingedly connected, such as by a pivot 956, to the firstextendable segment 944, allowing the second extendable segment 950 toarticulate with respect to the first extendable segment 944.

In one embodiment, the depending arm 940 of the shield 936 is orientedon a first side of the cannula 934. In another embodiment, the shield936 includes a second depending arm 970, as similarly described,oriented on a second side of the cannula 934, with the second side beingsubstantially opposite the first side. In a further embodiment, thedepending arm 940 and the second depending arm 970 may be connected,such as by a union 972. In another embodiment, the depending arm 940 andthe second depending arm 970 may be connected by at least one pivot 956.In a further embodiment, a pivot 956 may provide for an articulation ofless than 180 degrees.

In one embodiment, the orientation of the depending arm 940 and thesecond depending arm 970 provides for the flash chamber 998 to be easilyviewed when the shield is in the retracted position. In the retractedposition, as shown in FIG. 87, the extendable segments 948 are orientedin a substantially lateral orientation, such that a distal alignment end976 of the first extendable segment 944 is spaced apart from a proximalalignment end 978 of the second extendable segment 950. In oneembodiment, the distal alignment end 976 of the first extendable segment944 is offset or positioned within a distinct longitudinal plane fromthe proximal alignment end 978 of the second extendable segment 950 inthe lateral orientation. In a further embodiment, at least one of thedistal alignment end 976 of the first extendable segment 944 and theproximal alignment end 978 of the second extendable segment 950 areoffset from the transition axis W of the shield 936 in the lateralorientation.

The safety shield 936 may be transitioned from the retracted position tothe extended position by the application of manually applied force tothe release member 982 in the direction as shown by arrow H, shown inFIG. 87. In the partially extended position, as shown in FIG. 88, theforward urging of the base portion 952 initiates the first extendablesegment 944 to articulate about the pivot 956 until a proximal end 960reaches the apex position (shown in FIG. 88). As shown in FIG. 89,movement of the first extendable segment 944 advances the secondextendable segment 950 through pivot 956. Such movement may beaccomplished by continued forward movement of release member 982 in thedirection of arrow H, shown in FIG. 87, which causes movement of thebase portion 952, which in turn articulates the first extendable segment944. Alternatively, the extendable segments 948 may be constructed of amaterial having resiliency, so as to effect automatic movement once thefirst extendable segment 944 reaches an apex, thereby creating amechanism for automatic continued movement. In order to accommodate thismotion, the free end 986 of the second extendable segment 950 isadvanced along the transition axis W, shown in FIG. 87.

In the fully extended position, as shown in FIG. 91, the firstextendable segment 944 and the second extendable segment 950 areoriented in a substantially parallel orientation with respect to eachother along substantially the same longitudinal plane as the cannula 934in shielding orientation of the cannula 934. In the fully extendedposition the extendable segments 948 are substantially longitudinallyoriented, such that a distal alignment end 976 of the first extendablesegment 944 is substantially adjacent the proximal alignment end 978 ofthe second extendable segment 950. In one embodiment, the distalalignment end 976 of the first extendable segment 944 contacts theproximal alignment end 978 of the second extendable segment 950 alongthe same longitudinal plane W, as shown in FIG. 91.

The safety shield 936, specifically the first extendable segment 944 andthe second extendable segment 950, may have any suitable dimensions andconfiguration such that they are adapted to shield the cannula 934, andin particular the puncture tip thereof, when the safety shield 936 is inthe extended position. The safety shield 936 may be deployed over thecannula 934 while the cannula 934 is accessing the interior of thepatient's blood vessel (not shown), or after the cannula 934 has beenremoved from the patient. A locking mechanism, as similarly describedherein, may further be employed to prevent transition of the shield 936from the extended position to the retracted position once the shield 936has been transitioned from the retracted position to the extendedposition.

In one embodiment, the flash chamber 998 may be visible to medicalpractitioners in both the retracted position and the extended position,as well as in the partly extended position. In another embodiment,transition of the safety shield 936 from the retracted position to theextended position is accomplished without obstructing the view of theflash chamber 998. In this configuration, articulation of the safetyshield 936 occurs remotely from the viewpath of the flash chamber 998.For example, the pivots 956 may be positioned on the bottom portion ofneedle assembly 930, so as not to obstruct a direct top-line view of theflash chamber 998 by a medical practitioner.

FIGS. 92-93 depict another embodiment of the present invention, in whichneedle assembly 1030 is similarly as described above, with the exceptionof the configuration of safety shield 1036 and the attachment of safetyshield 1036 to the housing 1032. Needle assembly 1030 generally includesa cannula 1034 associated with the housing 1032, and a safety shield1036 adapted for safety shielding of the cannula 1034 during and/orafter use of the device. Needle assembly 1030 further includes a hub1064 for supporting the cannula 1034 and defining a flash chamber 1098therein, as previously described. At least a portion of the hub 1064 andthe flash chamber 1098 are visible through a portion of the safetyshield 1036 in the retracted position.

In one embodiment, the shield 1036 includes a depending arm 1006transitionable from a first position, shown in FIG. 92, in which thedepending arm 1006 is substantially perpendicular to the longitudinalaxis S of the cannula 1034 (shown in FIG. 92), to a second position,shown in FIG. 93, in which the depending arm is substantially orientedalong the longitudinal axis S of the cannula 1034. In one embodiment,the depending arm 1006 may include a first portion 1008 and a secondportion 1010 pivotally or hingedly connected therebetween.

A portion of the shield 1036 is adapted to at least partially surround,such as circumferentially surround, at least a portion of the tip of thecannula 1034 in the extended position shown in FIG. 93. In oneembodiment, the flash chamber 1098 is at least partially visible to amedical practitioner when the safety shield 1036 is in the retractedposition. In the retracted position, the first portion 1008 and thesecond portion 1010 are oriented in a substantially perpendicularorientation with respect to the axis of the cannula 1034, andsubstantially parallel to each other in the extended position. Theshield may further include a circular portion 1088 disposedcircumferentially about a portion of the cannula 1034. In oneembodiment, once the first portion 1008 and the second portion 1010 arealigned in substantially parallel orientation, the circular portion 1088may be advanced over the depending arm 1006, such as over the hinge 1090connecting the first portion 1008 and the second portion 1010, therebylocking the hinge 1090 in place.

In another embodiment, shown in FIGS. 94-106, another alternative hingedassembly embodiment of the present invention is shown. Needle assembly30 c 1 generally includes needle structure 32 c 1 associated with needleholder 42 c 1, and a safety shield 64 c 1 adapted for safety shieldingof the needle structure 32 c 1 after use of the device. Needle assembly30 c 1 further includes a hub 58 c 1 for supporting the needle structure32 c 1 and a flashback indicator 60 c 1 defined therein, as previouslydescribed.

In the embodiment shown in FIGS. 94-106, the safety shield 64 c 1 mayinclude a first depending arm 3000 and a second depending arm 3002substantially parallel to the first depending arm 3000. The firstdepending arm 3000 and the second depending arm 3002 are connectedtogether by a connection surface 3004 that is substantiallyperpendicular to the first depending arm 3000 and the second dependingarm 3002. The safety shield 64 c 1 has a proximal end 3006 adjacent theneedle holder 42 c 1 and a distal end 3008 opposed from the proximal end3006. At least a portion of the proximal end 3006 of the safety shield64 c 1 is pivotally connected to the needle holder 42 c 1. Preferably,the proximal end 3006 of the safety shield 64 c 1 is connected to theneedle holder 42 c 1 by two opposing pivots 3010. In a furtherembodiment, the safety shield 64 c 1 is pivotally connected to the frontcone 3012 of the needle holder 42 c 1 by pivots 3010 extending throughopposing attachment arms 3014 connected to the front cone 3012 andoriented along the longitudinal axis of the needle holder 42 c 1.

The pivot(s) 3010 allow the safety shield 64 c 1 to transitionally pivotin a rotational manner with respect to the needle holder 42 c 1 from aretracted position, as shown in FIGS. 98-101 to an extended position, asshown in FIGS. 102-104. In one embodiment, the safety shield 64 c 1 mayalso include a shield engaging area 3016 within the connection surface3004 adjacent the proximal end 3006 having a contour substantiallycorresponding to the contour of the exterior surface 3018 of the needleholder 42 c 1 and/or the exterior surface 3018 of the front cone 3012.In this configuration, the shield engaging area 3016 may rest against aportion of the needle holder 42 c 1 in the retracted position.

As shown in FIG. 97, the hub 58 c 1 may include a front hub portion 3026and a rear hub portion 3028 joined to the first hub portion 3026. Thefront hub portion 3026 may have a substantially conical shape disposedabout the flashback indicator 60 c 1. In one embodiment, at least aportion of the front hub portion 3026 extends distally beyond the frontcone 3012 of the needle holder 42 c 1. In another embodiment, at least aportion of the front hub portion 3026 has a contour that corresponds toa contour of the front cone 3012 of the needle holder 42 c 1. The rearhub portion 3028 of the hub 58 c 1 may include a disk structuredimensioned to contact an interior perimeter of the needle holder 42 c 1to prevent advancement of an evacuated blood collection tube (not shown)therebeyond. At least a portion of the needle structure 32 c 1 mayextend through the front hub portion 3026 and the rear hub portion 3028of the hub 58 c 1. Although the hub 58 c 1 may be provided within thecollection assembly as an integral element, in an alternativeconfiguration, the hub 58 c 1, including the front hub portion 3026 andthe rear hub portion 3028, as well as the needle structure 32 c 1 may beseparately formed and subsequently assembled within the collectionassembly 30 c 1.

In one embodiment, the needle assembly 30 c 1 may be provided with aremovable IV needle shield 3020 covering at least a portion of theneedle structure 32 c 1, such as covering at least a portion of thedistal needle portion 34 c 1. In one embodiment, as shown in FIG. 97,the needle shield 3020 can be sized to extend over at least a portion ofthe front hub portion 3026 of the hub 58 c 1, the front cone 3012 of theneedle holder 42 c 1, the flashback indicator 60 c 1, and/or the hub 58c 1. The needle shield 3020 can be removed from the needle assembly 30 c1 prior to use by typical manual applied pressure.

Referring again to FIG. 97, in another embodiment the needle shield 3020can be provided with a raised protrusion 3022 disposed on the exteriorsurface 3024 of the needle shield 3020. In one embodiment, the raisedprotrusion 3022 is circumferentially disposed about the needle shield3020. In another embodiment, the raised protrusion 3022 corresponds to anotch 3030 within the safety shield 64 c 1 such that the needle shield3020 cannot be accidentally released from the needle assembly 30 c 1until the safety shield 64 c 1 is positioned in the retracted position,as shown in FIGS. 98-101.

The safety shield 64 c 1 can be sized to have any dimensions suitable toallow the safety shield 64 c 1 to be pivoted away from the needlestructure 32 c 1 in the retracted position, as shown in FIGS. 98-101, toallow a medical practitioner to engage the needle structure 32 c 1 witha patient, and to pivot toward and shield the needle structure 32 c 1,specifically the tip of the distal needle portion 34 c 1 in the extendedposition, as shown in FIGS. 102-104. In one embodiment, the safetyshield 64 c 1 may be pivoted away from the axis of the needle structure32 c 1 to a sufficient angle to allow a medical practitioner to view theflashback indicator 60 c 1 and/or hub 58 c 1 in the retracted position.In another embodiment, the safety shield 64 c 1 is made of a transparentand/or translucent material to allow a medical practitioner to view theflashback indicator 60 c 1 and/or hub 58 c 1 therethrough.

Once the distal needle portion 34 c 1 has been removed from the patient,the needle assembly 30 c 1 may be transitioned from the retractedposition to the extended position. In one embodiment, the firstdepending arm 3000 and the second depending arm 3002 of the safetyshield 64 c 1 may be constructed to form a press-fit lock with at leasta portion of the front hub portion 3026, the front cone 3012 and/or theneedle holder 42 c 1. This prevents the safety shield 64 c 1 fromre-transitioning to the retracted position once the initial transitionfrom the retracted position to the extended position has occurred. Asshown in FIGS. 105-106, the first depending arm 3000 and the seconddepending arm 3002 may each include an inwardly angled restraint 3032disposed adjacent the pivot 3010 at the proximal end 3006 of the safetyshield 64 c 1. The angled restraint 3032 includes a sloped surface 3036and a restraining surface 3038. The front hub portion 3026 may alsoinclude a plurality of ledges 3034 for engaging the angled restraints3032. In one embodiment, when the safety shield 64 c 1 of the needleassembly 30 c 1 is transitioned from the retracted position to theextended position, the angled restraint 3032 of the safety shield 64 c 1engages the ledge(s) 3034 of the front hub portion 3026. Specifically,the restraining surface 3038 engages the ledge(s) 3034 and preventssubsequent movement of the safety shield 64 c 1. In one embodiment, theledge(s) 3034 are positioned on the distal end 3050 of the hub 58 c 1.In another embodiment, the angled restraint(s) 3032 are positioned onthe safety shield 64 c 1 at a location distal from the pivot(s) 3010 forcorrespondingly engaging the ledge(s) 3034 on the distal end 3050 of thehub 58 c 1. Alternatively, the front cone 3012 may also include aplurality of ledges 3034 a for engaging the angled restraint 3032 of thesafety shield 64 c 1. In yet another embodiment, the angled restraint(s)3032 are positioned on the superior side 3052 of the safety shield 64 c1 and may extend in a direction proximal from the pivot(s) 3010.Accordingly, the engagement of the safety shield 64 c 1 and the hub 58 c1 may occur at the superior side 3052 (bottom side), of the needleassembly 30 c 1. Transition of the angled restraint 3032 over theledge(s) 3034 can be effectuated with typical manual pressure. As shownin FIG. 106, the safety shield 64 c 1 may optionally include a biasingelement 3040 for further securing the front hub portion 3026 within thesafety shield 64 c 1. Thus, the locking structure of the safety shield64 c 1 engages at least a portion of the flash chamber, defined withinthe hub 58 c 1. In one embodiment, the locking structure of the safetyshield 64 c 1 engages at least a portion of the housing, such as the hub58 c 1, at a location distal to the flash chamber.

FIGS. 107-121 depict yet another alternative hinged assembly embodimentof the present invention. A needle assembly 5000, as shown in FIGS.107-113, generally includes a needle structure 32 c 2, associated with ahub 58 c 2, and a safety shield 64 c 2 connected to the hub 58 c 2 andadapted for safety shielding of the needle structure 32 c 2 after use ofthe device. In one embodiment, the needle assembly 5000 may incorporatefeatures of other known needle assemblies having hinged safety shields,such as those disclosed in United States Patent Publication No.2005/0187493, the entire disclosure of which is hereby incorporated byreference.

The needle structure 32 bc 2 may include a distal needle portion 5002and a proximal needle portion 5004. Distal needle portion 5002 andproximal needle portion 5004 may be separate needles, both of whichrepresent needle cannulae defining central lumen 5006 extendingtherethrough. The proximal needle portion 5004 represents a non-patientend of the needle structure 32 bc 2, which is provided for puncturing ofan evacuated blood collection tube (not shown). The proximal needleportion 5004 may be covered by an elastomeric multiple sample sleeve5008 that can be pierced by a pointed end of proximal needle portion5004 of the needle structure 32 c 2. Distal needle portion 5002represents a patient end of the needle structure 32 c 2, and may bebeveled to define a puncture tip for puncturing the skin of a patientand accessing the vasculature of the patient.

The hub 58 c 2 may include a front hub portion 5010 and a rear hubportion 5012 and is capable of supporting the needle structure 32 c 2therethrough. In one embodiment, the distal needle portion 5002 may beintegral with the front hub portion 5010 and the proximal needle portion5004 may be integral with the rear hub portion 5012. The front hubportion 5010 and the rear hub portion 5012 are structured to matinglyengage. The front hub portion 5010 may include a protrusion 5014, suchas a raised annular ring, for engaging a corresponding recess 5016integral to the rear hub portion 5012. In another embodiment, the fronthub portion 5010 and the rear hub portion 5012 may be joined togethervia an adhesive or weld. Once assembled, the hub 58 c 2 defines aflashback indicator 60 c 2 therein, as previously described.

The hub 58 c 2 may further include a collar 5018 for surrounding atleast a portion of the safety shield 64 c 2, such as a pivot 5020 of thesafety shield 64 c 2, as previously described herein. In one embodiment,the front hub portion 5010 includes a first collar portion 5022 and therear hub portion 5012 includes a second collar portion 5024. The firstcollar portion 5022 may include a generally c-shaped region 5028 foraccommodating an attachment bearing 5026 of the safety shield 64 c 2,shown in FIGS. 112 and 114, therein. The attachment bearing 5026 may beintegral with the safety shield 64 c 2. The attachment bearing 5026 mayalso be integral with a portion of the hub 58 c 2, such as the firstcollar portion 5022 and/or the second collar portion 5024.Alternatively, the attachment bearing 5026 may be separately providedand subsequently assembled with the safety shield 64 c 2 and/or the hub58 c 2. The attachment bearing 5026 can extend between a first dependingarm 5044 and a second depending arm 5046 of the safety shield 64 c 2, asshown in FIG. 115. The second collar portion 5024 may include a capregion 5030 having an interior surface 5032 substantially correspondingto the attachment bearing 5026 of the safety shield 64 c 2. The firstcollar portion 5022 may include a protrusion 5034 for engaging acorresponding recess 5036 integral to the second collar portion 5024.Accordingly, in one embodiment, the engagement of the front hub portion5010 with the rear hub portion 5012 also engages the first collarportion 5022 with the second collar portion 5024. In another embodiment,the collar 5018 is positioned substantially on a top surface of the hub58 c 2 to allow the safety shield 64 c 2 to likewise be connected to thetop surface of the hub 58 c 2.

Referring again to FIGS. 107-113, a proximal IV needle shield 5038 and adistal IV needle shield 5040 can be respectively provided over theproximal needle portion 5004 and the distal needle portion 5002 prior touse, as described herein.

During use, the proximal IV needle shield 5038 can be removed from theproximal needle portion 5004 and the needle holder 42 c 2, shown inFIGS. 115-121, can be inserted over the proximal needle portion 5004 andengaged with at least a portion of the hub 58 c 2. In one embodiment,the needle holder 42 c 2 is engaged with a portion of the rear hubportion 5012.

In another embodiment, shown in FIG. 114, the attachment bearing 5026 ofthe safety shield 64 c 2 may include a notch 5042 for retaining thesafety shield 64 c 2 within a specified location. For example, the notch5042 may frictionally retain the safety shield 64 c 2 within the collar5018 at a specified angle in the retracted position. This allows amedical practitioner to position the safety shield 64 c 2 at a desiredangle during a medical procedure without attending to accidental closureor slippage of the safety shield 64 c 2.

As shown in FIGS. 115-121, the needle assembly 30 c 2 can betransitioned from the retracted position, shown in FIG. 114, in whichthe distal needle portion 5002 is unshielded for the purpose ofaccessing a patient, to the extended position, in which the distalneedle portion 5002 is safety shielded from exposure, as describedherein. With reference to FIGS. 107-121, in another embodiment, thesafety shield 64 c 2 may include a thumb press-region 64 c 2 a forenabling a medical practitioner to pivot the safety shield 64 c 2 toengage a portion of the proximal IV shield 5038 prior to puncturing theskin of a patient. In one embodiment, the thumb press-region 64 c 2 aextends at least partially beyond the safety shield 64 c 2 to enable themedical practitioner to easily contact the thumb-press region 64 c 2 awith a single finger or thumb.

In an alternative embodiment, as shown in FIG. 122, a collectionassembly 130 w, may include a safety shield 64 w may include a first end138 w having a first depending arm 132 w and a second depending arm 134w substantially parallel to the first depending arm 132 w. The firstdepending arm 132 w and the second depending arm 134 w may be connectedtogether. The first depending arm 132 w and the second depending arm 134w may have substantially the same area. The safety shield 64 w has anend 140 w that is connected to the needle holder 42 w by at least onepivot 142 w. Preferably, the end 140 w of the safety shield 64 w isconnected to the needle holder 42 w by two pivots 142 w. Examplepivoting mechanisms are described in United States Patent PublicationNo. 2005/187,493, the entire content of which is herein incorporated byreference.

In one embodiment, the pivot 142 w may include a protrusion integrallyformed with the second end 140 w of the safety shield 64 w and acorresponding recess defined in the distal end of the needle holder 42w. In another embodiment, the pivot 142 w may include a recess definedwithin the second end 140 w of the safety shield 64 w and acorresponding recess defined within the distal end of the needle holder42 w. In yet another embodiment, a first pivot 142 w can be disposed ona first side of the distal end of the needle holder 42 w and a secondpivot 142 w can be disposed on a second side of the distal end of theneedle holder 42 w, the first and second sides of the needle holder 42 wbeing substantially opposite each other. The pivot(s) 142 w allow thesafety shield 64 w to pivot in a rotational manner with respect to theneedle holder 42 w from a retracted position, as shown in FIG. 122 to anextended position, as previously described.

In yet another embodiment of the invention, shown in FIGS. 123-125, theneedle assembly 1130 includes a specimen collection container holder1101 having a pierceable or punctureable shield 1102 disposed over theproximal end 1103 of the specimen collection container holder 1101 toprovide a sterile environment within the interior of the specimencollection container holder 1101 prior to use. In one embodiment, thepierceable or punctureable shield 1102 is made of a paper, polymeric,and/or thin metal film having perforated sections therein which may bepierced by standard manually applied pressure. In use, a medicalpractitioner may insert any conventionally known specimen collectioncontainer 1105, such as a blood collection tube, into the proximal end1103 of the specimen collection container holder 1101 through thepierceable or punctureable shield 1102.

The needle assembly 1130 may then be used in any manner as previouslydescribed herein to perform a medical procedure and/or shield a cannula1134 after use. After use, the pierceable or punctureable shield 1102may remain attached to the specimen collection container holder 1101 toprovide a clear indication of use of the needle assembly 1130.Accordingly, a needle assembly 1130 including a pierceable orpunctureable shield 1102 provides a clear tamper and/or use indicator toa medical practitioner. The pierceable or punctureable shield 1102described herein is suitable for use with any of the above-describedcollection assemblies. It is further contemplated that a separate,removable liner (not shown) may be affixed, such as through a removableadhesive, over the outer surface of shield 1102. Such a removable linerprovides further sterility and barrier protection prior to the use. Inaddition, the pierceable or punctureable shield 1102 may be applied tothe proximal end 1103 of the specimen collection container holder 1101as a prepackaged device with the need for additional external packaging.

FIGS. 126-131 illustrate yet a further embodiment of the presentinvention in which the housing 7000 of a needle assembly, shown in FIGS.130-131, as previously described herein, includes a base portion 7002,shown in FIGS. 126-127, and a hub portion 7004, shown in FIGS. 128-129,engageable with the base portion 7002. Referring to FIGS. 126-127, thebase portion 7002 has a distal end 7006 and a proximal end 7008 with asidewall 7010 extending therebetween. In one embodiment, the sidewall7010 defines at least one opening 7012 through which a first portion7016 of the hub 7004, shown in FIG. 128, may be received. In anotherembodiment, the opening 7012 is adapted to allow a first portion 7016 ofthe hub 7004, to pass from an interior 7022 of the base portion 7002through the sidewall 7010 to a position external to the interior 7022 ofthe base portion 7002. In another embodiment, the sidewall 7010 definesa second opening 7014 through which a second portion 7018 of the hub7004, shown in FIG. 128, may be received. In yet another embodiment, thefirst opening 7012 of the base portion 7002 may be aligned in asubstantially opposed orientation with respect to the second opening7014, such that the first opening 7012 and the second opening 7014 arealigned along a common through-axis Z, as shown in FIG. 126. In afurther embodiment, the sidewall 7010 of the base portion 7002 mayinclude a release member opening 7020 through which a release member7040, shown in FIGS. 130-131 and as previously described, may bereceived.

As shown in FIGS. 128-129, the hub 7004 may include a first portion 7016extending in a substantially radial orientation from a body portion 7024of the hub 7004. In another embodiment, the hub 7004 may include asecond portion 7018 extending in a substantially radial orientation fromthe body portion 7024 of the hub 7004 and aligned in a substantiallyopposed orientation with respect to the first portion 7016, such thatthe first portion 7016 and the second portion 7018 are aligned at leastpartially along a common axis Y, as shown in FIG. 128. In anotherembodiment, the common axis Y of the hub portion 7004 may be alignablewith the through-axis Z of the base portion 7002, shown in FIG. 126.

As shown in FIGS. 130-131, the hub portion 7004 may be at leastpartially insertable within the base portion 7002 such that the firstportion 7016 of the hub 7004 extends at least partially through theopening 7012 defined within the sidewall 7010 of the base portion 7002.In another embodiment, the hub portion 7004 may be at least partiallyinsertable within the base portion 7002 such that the first portion 7016of the hub portion 7004 extends at least partially through the opening7012 defined within the sidewall 7010 of the base portion 7002, and thesecond portion 7018 of the hub extends at least partially through thesecond opening 7014 defined within the sidewall 7010 of the base portion7002. In yet another embodiment, the hub portion 7004 may be insertableinto the interior 7022 of the base portion 7002 through the proximal end7008. In yet another embodiment, at least one of the first portion 7016and the second portion 7018 are deflectable against an interior wall7026 of the interior 7022 of the base portion, such as adjacent theproximal end 7008 during insertion of the hub portion 7004 into the baseportion 7002. In yet a further embodiment, at least one of the firstportion 7016 and the second portion 7018 include a grippable region 7030enabling a user to easily contact the housing 7000 when the hub portion7004 is disposed within the base portion 7002. In one embodiment, thegrippable region 7030 includes a plurality of ribs 7032.

While specific embodiments of the invention have been described indetail, it will be appreciated by those skilled in the art that variousmodifications and alternatives to those details could be developed inlight of the overall teachings of the disclosure. The presentembodiments described herein are meant to be illustrative only, and notlimiting as to the scope of the invention, which is to be given the fullbreadth of the appended claims and any and all equivalents thereof.Various other embodiments will be apparent to, and readily made by thoseskilled in the art, without departing from the scope and spirit of theinvention.

What is claimed is:
 1. A needle assembly, comprising: a housing having adistal portion and a proximal portion engageable with a specimencollection container; a cannula having a patient end, a non-patient end,and a sidewall extending therebetween defining a cannula interior, thepatient end of the cannula projecting at least partially from the distalportion of the housing; and a shield restrainably engaged with a portionof the housing and axially transitionable over the patient end of thecannula from a retracted position in which the patient end is exposed,to an extended position in which the patient end is shielded by at leasta portion of the shield, wherein the shield comprises a first portionfor slideably engaging an outer surface portion of the housing and asecond portion at least partially surrounding a portion of the cannulain the extended position, wherein the second portion of the shieldcomprises a depending arm transitionable from a first position in whichthe depending arm is substantially perpendicular to a longitudinal axisof the cannula, to a second position in which the depending arm isoriented substantially along the longitudinal axis of the cannula. 2.The needle assembly of claim 1, wherein the depending arm comprises afirst portion and a second portion, the first portion and the secondportion pivotally or hingedly connected therebetween.
 3. A needleassembly, comprising: a housing having a distal portion and a proximalportion engageable with a specimen collection container; a cannulahaving a patient end, a non-patient end, and a sidewall extendingtherebetween defining a cannula interior, the patient end of the cannulaprojecting at least partially from the distal portion of the housing;and a shield restrainably engaged with a portion of the housing andaxially transitionable over the patient end of the cannula from aretracted position in which the patient end is exposed, to an extendedposition in which the patient end is shielded by at least a portion ofthe shield, wherein the shield comprises a first portion for slideablyengaging a portion of the housing, and a second portion at leastpartially surrounding a portion of the cannula in the extended position,wherein the housing comprises a first portion and a second portion, thefirst portion of the housing distal to the second portion of thehousing, and wherein the shield includes a distal end that is entirelydisposed within an interior of the first portion of the housing in theretracted position, and a specimen collection container receiving portis defined within the second portion.
 4. The needle assembly of claim 3,wherein the first portion and the second portion of the housing areseparate components that are assembled together.
 5. A needle assembly,comprising: a housing having a distal portion and a proximal portionengageable with a specimen collection container; a cannula having apatient end, a non-patient end, and a sidewall extending therebetweendefining a cannula interior, the patient end of the cannula projectingat least partially from the distal portion of the housing; and a shieldrestrainably engaged with a portion of the housing and axiallytransitionable over the patient end of the cannula from a retractedposition in which the patient end is exposed, to an extended position inwhich the patient end is shielded by at least a portion of the shield,wherein the shield comprises a depending arm slideably attached to anexterior of the housing, the depending arm comprising a plurality ofextendable segments, wherein the extendable segments are substantiallylaterally oriented in the retracted position and substantiallylongitudinally oriented in the extended position.
 6. The needle assemblyof claim 5, wherein the plurality of extendable segments are pivotallyconnected therebetween.
 7. The needle assembly of claim 5, wherein theplurality of extendable segments are hingedly connected therebetween. 8.The needle assembly of claim 5, wherein the depending arm comprises afirst depending arm is oriented on a first side of the cannula, andfurther comprising a second depending arm oriented on a second side ofthe cannula, the second side substantially opposite the first side,wherein the first and second depending arms are slideably attached tothe exterior of the housing.
 9. The needle assembly of claim 1, whereinthe first portion of the shield includes a circular portion disposedcircumferentially about a portion of the cannula.
 10. The needleassembly of claim 9, wherein advancement of the shield to the extendedposition causes the circular portion to lock the second portion of theshield in the extended position.
 11. The needle assembly of claim 9,wherein the depending arm comprises a first portion and a secondportion, the first portion and the second portion pivotally or hingedlyconnected therebetween and wherein transition of the depending arm fromthe first position to the second position causes the circular portion toadvance over the connection of the first portion and second portion ofthe depending arm to lock the shield in the extended position.
 12. Theneedle assembly of claim 3, wherein the safety shield is formed from aresilient deformable material capable of being folded against itself inan accordion folding arrangement.
 13. The needle assembly of claim 3,including a spring biased between a portion of the safety shield and aportion of the first portion of the housing for transitioning the shieldfrom the retracted to the extended position.
 14. The needle assembly ofclaim 3, including a release member for actuating the transition of thesafety shield from the retracted position to the extended position, saidrelease member including a passage region and a retraining portion forholding the shield in the retracted position, said passage regiondefining a circular opening having a first diameter and said retrainingportion defining a circular opening having a second diameter which issmaller than the first diameter, wherein actuation of the release membercauses the shield to become aligned with the passage region allowing theshield to transition to the extended position.
 15. The needle assemblyof claim 8, including a release member extending between and associatedwith the first and second depending arms and wherein manual activationof the release member causes the shield to be transitioned from theretracted to the extended position.